Kala Azar

Diagnosis
and
Treatment
Protocol

For use by senior medical staff

in South Sudan projects

MSF Holland
February 2016
1. INTRODUCTION TO KALA AZAR 4

2. CLINICAL FEATURES (SIGNS & SYMPTOMS) OF KALA AZAR 5

2.1 History 5
2.2 Clinical examination 5

3. TYPES OF KALA AZAR 7

3.1 Primary Kala Azar 7
3.2 Relapse Kala Azar 7
3.3 Treatment after interruption 7
3.4 PKDL and PKMDL 7

4. DIAGNOSIS OF KALA AZAR 8

4.1 Case definition 8
4.2 Diagnostic tests 8
4.3 Choice of diagnostic method 9

5. DIFFERENTIAL DIAGNOSIS FOR PATIENTS WITH

NEGATIVE DAT, IT LEISH OR ASPIRATE TEST 11
5.1 Malaria 11
5.2 Typhoid fever 11
5.3 Typhus 11
5.4 Brucellosis 11
5.5 Schistosomiasis (Bilharzia) 11
5.6 Splenic abscess 11
5.7 Extrapulmonary Tuberculosis 12
5.8 Tropical splenomegaly 12
5.9 AIDS/HIV 12
5.10 Leukaemia (Chronic Myeloid Leukaemia) 12

6. HIV AND KALA AZAR – PROVIDER INITIATED COUNSELLING AND TESTING 12

7. ADMISSION TO THE KALA AZAR PROGRAMME – ADMISSION CHECKLIST 13

7.1 Explanations to the patient 13
7.2 Non food items 13
7.3 Routine drugs 13
7.4 Filling in the patient card 13

8. TREATMENT REGIMEN 15
8.1 PHCU 15
8.2 PHCC/Hospital 15
8.3 Treatment of Kala Azar in HIV positive patients 17
8.4 Summary table: Treatment of Leishmaniasis 18
8.5 Daily routine 19
8.6 Weekly activities 20

9. PATIENT EDUCATION 21
9.1 Bed nets 21
9.2 Water 21
9.3 Latrines 21
9.4 Personal hygiene 21
9.5 Coughing 21

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 10. DRUGS USED TO TREAT KALA AZAR 22
10.1 Sodium Stibogluconate (SSG) 22
10.2 Paromomycin (PM) 23
10.3 AmBisome 24
10.4 Miltefosine 25

11. INJECTIONS 26
11.1 Preparations 26
11.2 Practical execution 26

12. INTERCURRENT ILLNESSES 27

12.1 Diarrhoea 27
12.2 Vomiting 27
12.3 Dehydration 28
12.4 Cough 29
12.5 Bleeding 30
12.6 Eye infection 31
12.7 Ear infection 31
12.8 Skin and wound infections 31
12.9 Malaria 32
12.10 PKMDL Iritis 32
12.11 TB co-infection 32
12.12 HIV co-infection 32

13. DISCHARGE PROCEDURE 33

13.1 Clinical cure/Test of Cure (TOC) 33
13.2 Examination and recording on the patient card 33
13.3 Discharge drugs 33
13.4 Discharge card 34

14. DEFAULTING PROCEDURE 34

15. SEVERE KALA AZAR 35

15.1 Scoring the patient 35
15.2 Treatment 36

ANNEX 1: Testing procedures 37

ANNEX 2: Drug dosages 41

ANNEX 3: Treatment algorithms 46

Abbreviations used:
ART = Anti-Retroviral Therapy
BMI = Body Mass Index
d = day
DAT = Direct Agglutination Test
Hb = Haemoglobin
HIV = Human Immunodeficiency Virus
IT = Individual Test
KA = Kala Azar, same as VL = Visceral Leishmaniasis
kcal = kilocalorie
MSF = Médecins Sans Frontières [french] = Doctors Without Borders
PHCU = Primary Healthcare Unit
PHCC = Primary Healthcare Center
PICT = Provider Initiated Counselling and Testing (for HIV)
PKA = Primary Kala Azar
PKDL = Post-Kala Azar Dermal Leishmaniasis
PKMDL = Post-Kala Azar Mucosal-Dermal Leishmaniasis, same as PKDL Grade 3
PM = Paromomycin
RDT = Rapid Diagnostic Test
SSG = Sodium Stibogluconate (also known as Pentostam®)
TB = Tuberculosis 3
TOC = Test of Cure
1. INTRODUCTION TO KALA AZAR
Kala Azar, also called Visceral Leishmaniasis or VL, is a disease spread by sand flies
(Phlebotomus orientalis). These small insects live in the Red Acacia trees found in South
Sudan. The sand fly ingests the Kala Azar parasites during biting a Kala Azar infected person.
The Kala Azar parasite (Leishmania donovani) that lives inside the sand fly enters the body
when a healthy person is bitten by an infected sand fly.
The parasite affects specific cells (macrophages) of the immune system - the body’s defence
army against diseases. These cells are mainly found in the spleen, the lymph nodes, and the
bone marrow (where the blood is made, inside the long bones). This is the reason for a
person with Kala Azar to present with a big spleen (splenomegaly), anaemia and often
enlarged lymph nodes.

Kala Azar patients have very few red blood cells. This is called anaemia and makes the
patient feel very tired and weak.
Kala Azar patients also have very few cells necessary for the clotting of blood (platelets), so
they bleed easily and sometimes a lot.
Kala Azar patients also have very few white blood cells, meaning that the immune system
(body’s “defence army”) is weak. The body cannot fight infections well. Kala Azar patients
get severely ill, and infections such as pneumonia and diarrhoeal diseases are very common
among these patients. They can easily die from these infections.
Kala Azar patients lose a lot of weight, and most of them are malnourished on admission.

Strongly enlarged picture of a sand fly – the life size is only 2 – 4 mm (smaller than a grain of rice)!

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2. CLINICAL FEATURES (SIGNS & SYMPTOMS) OF KALA AZAR
2.1. History
It is very important that you start your consultation with taking the history. Let the patient
tell their complaints, and then ask them specifically about the symptoms in the list below.
Specific questions will help the patients to remember, in case they forgot some of the
symptoms.

Symptoms % of patients suffering from it

Fever (mainly in the afternoon) 95
Uncomfortable spleen 85
Wasting (weight loss) 80
Loss of appetite 70
Cough 75
Epistaxis (nose bleeding) 50
Diarrhoea 40
Vomiting 15
Oedema (swelling of the feet) 5
Jaundice (yellowish discoloration of the eyes) 5

You must also ask:

• How long has the patient been sick? (Kala Azar patients are sick longer than 2 weeks
but rarely longer than 6 months).
• Has the patient been treated for Kala Azar before? If yes: How long ago was he/she
treated? What treatment was given? Which route was used (IM/IV/PO)? How long did
the treatment take?
This will determine the (suspected) type of KA and thus the diagnostic test to use
(and, if they test positive for Kala Azar, to choose the best treatment).

2.2. Clinical examination

• Does the patient look sick?
• Look for signs of anaemia in the eyes, tongue and hands (very pale or white).
• Look for jaundice in the eyes (yellow colour).
• Examine the groin, neck and armpits for enlarged lymph nodes.
• Count and record the respiratory rate and auscultate the lungs, to find out if the
patient has pneumonia.
• Check and record the degree of dehydration.
• Get the patient to lie down and check for the size of the spleen: measure the
spleen size using a tape measure along the mid-clavicular line (the line starting
from the middle of the collarbone [clavicula] downwards) from the bottom of the
ribs along the direction of growth; record the size of the spleen in cm.
• Examine for an enlarged liver: measure the liver size the same way you measured
the spleen size; record the size of the liver in cm.
• Check and record the temperature.
• Press the front of the shins with your thumb in one place for three full seconds and
release, to find out if there is fluid in the tissue (oedema).
• Check whether the patient has Malaria (RDT [Paracheck] or blood film).

5
This table shows what proportions of patients have the following signs:

Signs % of patients presenting with it

Splenomegaly 95
Lymphadenopathy 75
Anaemia (pale conjunctives) 75
Hepatomegaly 60
Jaundice 5
Oedema 5

Patients with Kala Azar have been sick for more than 2 weeks.
They could be referred from other clinics, MSF OPD/IPD or be self referral cases.

You must always ask patients whether they have recently been tested positive for Malaria
and completed a full course of treatment with an antimalarial. If not, do a rapid test for
Malaria (SD Bioline) on all suspected Kala Azar patients. If the test result is positive, treat
the patient with Artesunate/Amodiaquine (see protocol or Annex 2 for dosage). If the
patient has received Malaria treatment in the past three weeks, ask the lab for blood film
microscopy for Malaria parasites, because the RDT will remain positive for several weeks
after end of treatment.

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3. TYPES OF KALA AZAR
3.1. Primary Kala Azar (PKA)
Primary KA is defined as when patients have Kala Azar for the first time.

3.2. Relapse Kala Azar

Relapse is defined as when patients come with Kala Azar after previous successful treatment
for KA. Most relapses occur within 6 months of initial discharge; these are called first
relapses. A patient who had a first relapse, was re-treated and got cured again, can get a
second relapse. Patients who relapsed already once have a higher chance of a second
relapse, and a higher chance of failing to respond to treatment – because of host factors
(HIV, TB etc) and because of parasite drug resistance.
• First Relapse: patients who present with KA after previous treatment for KA once.
• Second Relapse: patients who present with KA after treatment for a first relapse.
• Third Relapse: patients who present with KA for the third time after treatment for a
second relapse.

3.3. Treatment after interruption

For a patient who already received partial treatment and comes back after defaulting, or if
the treatment is re-started after it was interrupted by the doctor or the nurse due to
development of side effects, it is called “Treatment after interruption”.

3.4. PKDL and PKMDL

PKDL and PKMDL stand for “Post-Kala Azar Dermal Leishmaniasis” and “Post-Kala Azar
Mucosal-Dermal Leishmaniasis”. These pathologies are immunological complications of
successful treatment of Kala Azar, and usually develop shortly after treatment for Kala Azar,
but sometimes appear already during treatment. They occur if not all the parasites have
been killed, but instead they leave the internal organs to move to the skin.
PKDL starts with lumps (papules) on the face and can spread to the chest, back and arms.
When it affects the nose, mouth and eyes and causes sores, it is called PKMDL.

In most cases PKDL is mild and does not need treatment. It doesn’t look nice but otherwise
it will not harm the person; it disappears by itself after some time. A person with PKDL
should take extra care to sleep under a mosquito net (like all patients with Leishmania
infections) to prevent spreading the Kala Azar parasites to the sand flies and thus to other
people.

Grading:
Grade 1 PKDL – the rash is only on the face
Grade 2 PKDL – the rash is also on the chest and other parts of the body
Grade 3 PKDL or PKMDL – the rash is dense and covering most parts of the body, and
may be crusting or scaling; there may be sores in the nose and/or mouth, or the eyes
are affected (PKMDL)

Only severe Grade 2 PKDL (disfiguring nodules in the face) and Grade 3 PKDL/PKMDL require
treatment, especially if the eyes are affected (risk of blindness).

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4. DIAGNOSIS OF KALA AZAR

4.1. Case definition

To diagnose Primary Kala Azar or Relapse Kala Azar, a patient must first meet the criteria of
the case definition for suspected Kala Azar.
You should only test patients who fit the case definition:

History of fever for more than 2 weeks

and
Splenomegaly
or
Lymphadenopathy
or
Wasting (W/H <-2 Z-score or <16 BMI)

4.2. Diagnostic tests

4.2.1. IT Leish rapid test (rK39)

This is a rapid dipstick test that is very specific. This means that if the patient meets the
clinical case definition, and the test is positive, the patient does have KA, although it might
miss some cases (false negative results).
See Annex 1 on how to perform the test.
The test stays positive for a long time even after the patient is cured; therefore, do NOT use
the test if a patient has had KA before. Patients fitting the case definition with a high
suspicion of KA and a negative IT Leish test should get a DAT (see below).

4.2.2. DAT (Direct Agglutination Test)

DAT is used to diagnose Primary Kala Azar in KA suspect cases, and is more sensitive than
the IT Leish. This test is done in a laboratory, but the sample can be taken anywhere (see
Annex 1). The DAT test stays positive for a long period of time even after the patient is
cured; so do NOT use the test if a patient has had KA before. If the DAT test does not give a
clear result (“borderline”), refer the patient for a spleen or lymph node aspirate.

4.2.3. Aspirates

Microscopic examination of tissue smear obtained by either lymph node or spleen aspiration
is the only way to diagnose relapses. Spleen aspirate is the most reliable and sensitive, but
it must be done by a doctor or well trained senior medical person, as the procedure bears a
certain risk of bleeding. Avoid spleen aspirate in patients with: bleeding tendency (e.g.
frequent nose bleeding) or a history of bleeding, low haemoglobin (<5), jaundice, spleen
size below 2-3 cm, young children and pregnant women.
Lymph node aspirates can be done safely by trained staff, but are less sensitive than spleen
aspirates (many false-negative tests).

4.2.4. Clinical diagnosis – PKDL/PKMDL

Diagnosis of PKDL/PKDML is based on clinical presentation and history.

Check appearance and distribution of lesions.

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4.3. Choice of diagnostic method

4.3.1. PHCU Protocol

Diagnostic algorithm for Primary KA on PHCU level

Suspected Kala Azar
and no history of previous treatment for KA

IT Leish (rK39) +
-
Direct Agglutination Test (DAT)

Negative Borderline Positive

< 1/400 1/800 – 1/3200 > 1/3200

Refer to PHCC for aspirate

Non Kala Azar

Kala Azar
→ search other
diagnosis + treat
→ treat

Severely sick patients eligible for AmBisome treatment (see chapter 15.) should be referred
to PHCC for treatment.

Suspected relapse patients (clinical suspected KA with history of previous treatment for KA)
should be referred to PHCC for aspirate diagnosis.

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4.3.2. PHCC Protocol

Diagnostic algorithm for Primary KA on PHCC level

Suspected Kala Azar
and no history of previous treatment for KA

IT Leish (rK39)
+
-
Direct Agglutination Test (DAT)

Negative Borderline Positive

< 1/400 1/800 – 1/3200 > 1/3200

Spleen or lymph node aspiration

Non Kala Azar

Kala Azar
→ search other - +
diagnosis + treat → treat

Diagnostic algorithm for Relapse KA

Suspected Kala Azar
and history of previous treatment for KA

Spleen or lymph node aspiration

- +
Non Kala Azar Kala Azar
→ search other → treat
diagnosis + treat

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4.3.3. Clinical suspicion and negative tests

In some clinically suspect patients the rK39, DAT and lymphnode aspirate are negative, and
only after several attempts the lymphnode aspirate turns positive, resulting in significant
treatment delay. (Splenic aspirates are more sensitive). In such cases a quantitative DAT
test can give earlier confirmation of disease. An increasing DAT titre between two DAT tests
5-7 days apart is adequate confirmation, even of the titres are still below the positive
threshold of 1:6,400.

5. DIFFERENTIAL DIAGNOSIS FOR PATIENTS WITH NEGATIVE

DAT, IT LEISH OR ASPIRATE TEST

In South Sudan there are several other diseases that may clinically look like Kala Azar
(prolonged fever, splenomegaly):

5.1. Malaria
Although acute Malaria makes people sick for just a few days, there are also chronic forms
of Malaria. Children who suffered from Malaria many times may have a big spleen, but it
usually feels firmer. They can be malnourished under this condition too. But once you have
treated the Malaria properly, they should improve quickly.
Treat with Artesunate/Amodiaquine (see Annex 2).

5.2. Typhoid fever

• High fever
• Bradycardia (slow heart rate)
• Duration less than 1 month
• Impaired mental status (confusion)
• Constipation or diarrhoea
• Acute abdomen

See PHCC protocol.

5.3. Typhus
• Fever – variable length
• Hepatosplenomegaly
• Bleeding tendency
• Treatment: Doxycycline 200 mg PO single dose

5.4. Brucellosis
Patients have a long history of fever, little or moderate splenomegaly and an enlarged liver.
Usually there is also joint or bone pain. If you suspect Brucellosis, refer to PHCC.

5.5. Schistosomiasis (Bilharzia)

The patients may present with a very large liver and spleen, which they have often had for a
very long time. Most patients are not so unwell, usually with no fevers, although sometimes

11
they might have a liver damage which causes ascites (fluid in the abdomen).
Stool or urine analysis will show eggs of Schistosoma.
Treatment: Praziquantel.
NB: Inform the patient that treatment will not reduce spleen and liver size immediately; it
will just stop the disease getting worse.

5.6. Splenic abscess

This is unusual; it makes the patient very sick. Patients have high fever and a very tender
spleen. They may tell you that someone in the village has cut or injected them. Pus will be
seen on a spleen aspirate.
Treatment: Metronidazole and Ciprofloxacin.

5.7. Extrapulmonary Tuberculosis

Patients present with malnutrition and a history of fevers for up to several months. They
will not have an enlarged spleen, but they may have very large lymph nodes (depending on
the type of TB).
Refer to a TB treatment center.

5.8. Tropical splenomegaly

This is an immunological reaction to Malaria. The patients may have had a very large spleen
(often combined with an enlarged liver) for years. There is no fever.
For management, only thing to do is exclude acute Malaria.

5.9. AIDS/HIV
The HI virus damages the immune system, so that the body of an infected person cannot
properly fight against diseases. Patients often get diarrhoea, which may lead to
malnutrition/wasting and dehydration like in a Kala Azar patient. They may also have cough,
oral thrush (white coating on the tongue), Herpes zoster rash (Shingles) or scars, as well as
other infections.
Make sure to treat all the other diseases potentially associated with HIV infection.
If possible, refer to a facility offering ART.

5.10. Leukaemia (Chronic Myeloid Leukaemia)

These patients have fever, a big spleen and episodes of bleeding. They are also susceptible
to other infections. Blood testing shows a high white blood cell count.
Refer to hospital.

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6. HIV AND KALA AZAR – PROVIDER INITIATED COUNSELLING
AND TESTING
Provider Initiated Counselling and Testing (PICT) for HIV should be performed on all
confirmed KA patients (according to standard procedures), because the result will determine
their KA treatment - there is a high risk for SSG toxicity-related mortality in HIV co-
infected patients! – and ART should be started as soon as possible to improve immunity and
reduce the risk of relapse.

All confirmed HIV/KA co-infected patients must get an aspirate to determine the baseline
parasite load, to be able to check later on the efficacy of treatment through a test-of-cure
(TOC).

If a patient is too ill to receive PICT on admission, he/she should automatically be entered
into the regimen for severe KA (see 15.).
Counselling and Testing should be discussed with the patient as soon as the condition allows.

7. ADMISSION TO THE KALA AZAR PROGRAMME –

ADMISSION CHECKLIST

7.1. Explanations to the patient

Explain the disease, the program, the specific treatment and its expected duration
(including the possibility of prolongation), the special nutritional needs, possible side effects
and the decision on the end of treatment (clinical, TOC). Make sure the patients understand
that it is very important to come every day for their injections!
Take your time to answer any questions that might arise; this will create trust and increase
adherence to the treatment.
Keep in mind that the South Sudanese know Kala Azar and its traditional treatment (SSG).
The later developments (AmBisome and Miltefosine) are not well known yet, therefore a
good explanation is crucial for adherence.

7.2. Non food items

Give a cup, a bar of soap, a blanket and a mosquito net to each patient on admission.

7.3. Routine drugs

Give Vitamin A (Retinol) and Folic acid routinely; see Annex 2 for dosage.
Vaccinate all patients between 6 months and 16 years of age against Measles on the day of
admission if they do not have documented proof of vaccination.
Because children with KA are immunosuppressed, vaccine efficacy is expected to be lower.
Therefore it is recommended that children receive a second measles dose on discharge,
even if this is less than one month after the vaccination on admission.

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7.4. Filling in the patient card
The patient card always needs to be filled in diligently - all the information is very
important for follow up, treatment decisions and program improvement.

The patient card must contain:

• Patient number (serial number) according to the KA register: ensures that only a KA
patient gets treated for KA. Important for follow up in case of PKDL or relapse.

• Name of KA treatment center: to estimate the distance to the place of residence.

• Name of the patient.

• Date of admission to the program.

• Referred from: self-referral, other health structures, or outreach team.

• Sex of the patient: women of reproductive age must start contraception when put
Miltefosine (see 10.).

• Age in months or years: part of severity scoring (see 15.).

• Place of residence for the past 6 months: county, payam and village. Important for
mapping of cases and tracing of defaulters.

• Previous KA treatment: if yes – try to find out as many details as possible. Where, what
test was used, which drug was given for how long? Previous treatment history is essential
to classify patients as relapse, treatment after interruption or PK(M)DL.

• Duration of illness in months before admission.

• Indicator of weakness: collapse/severely weak/other. Part of severity scoring (see 15.).

• Weight in kg: to calculate drug dosage and evaluate response to treatment.

• Height in cm (children) or m (adults).

• Nutritional status on admission: Part of severity scoring (see 15.).

Z-score for children and adolescents less than 19 years:
The Z-score expresses the weight of a child or an adolescent in relation to his/her
height, and thus the nutritional status.
The Z-score table shows the deviation from the median weight for a given height:
<-2 Z-score means moderate malnutrition, <-3 Z-score means severe malnutrition.
Body Mass Index (BMI) for adults above the age of 18:
BMI expresses the weight of an adult in relation to his/her height, and thus the
nutritional status.
Calculation of BMI:
Weight in kg divided by height in metres divided by height in metres again = BMI
Example: patient weight 58 kg and height 1.67 m -> 58 ÷ 1.67 ÷1.67 = 20.8 BMI
BMI <16 means severe malnutrition.

• Size of spleen and liver on admission in cm: to evaluate response to treatment.

• Lymphadenopathy: yes/no.

• Haemoglobin (Hb) in g/dl: part of severity scoring (see 15.).

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• Pregnancy: yes/no. Different treatment regimen for pregnant women.

• Jaundice: yes/no. Different treatment regimen for jaundiced patients.

• Oedema: -/+/++/+++.

• Overall severity score: see 15. To determine treatment regimen.

• TB co-infection: yes/no.

• VCT code: encoded HIV serostatus. Different treatment regimen for HIV co-infected
patients.

• Date and result of IT Leish (OptiLeish) test.

• Date and result of DAT test in well titre, if done.

• Date and result of microscopy of spleen or lymph node aspirate in grading, if done.

• Final diagnosis: Primary KA (PKA), Relapse KA, or PKDL/PKDML.

• Date of start of treatment, treatment regimen and dosage.

• Routine drugs and other treatments, if any.

• Vital signs: temperature, pulse rate, blood pressure (in adults), respiratory rate.

• Comprehensive medical history: ask specifically for vomiting, diarrhoea, bleeding and
cough.

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8. TREATMENT REGIMEN

8.1. PHCU
8.1.1. Primary Kala Azar

Paromomycin for 17 days and SSG for 17 days (PM17/SSG17).

8.1.2. PKDL/PKMDL

Paromomycin for 17 days and SSG for up to 30 days (PM17/SSG30).

Refer to PHCC if there is no improvement after 30 days of SSG.

8.1.3. Severe Kala Azar, Relapse & Severe PKMDL

Refer suspected relapses and severe cases of PKA and PKMDL to PHCC.

8.2. PHCC/Hospital
8.2.1. Primary Kala Azar
Provider Initiated Counselling and Testing - PICT (also if tested negative before)

• HIV negative (tested) patients, or patients who refuse HIV testing:

Assess severity – see 15.

If severity score is <5:
Paromomycin for 17 days and SSG for 17 days (PM17/SSG17).

TOC is not needed if clinically cured; if the condition has improved and symptoms have
disappeared, a patient can be discharged (see chapter 13.1).

If the patient has not clinically responded well to treatment (e.g. still has fever, is still
feeling ill, no appetite, or no reduction of spleen size), do a TOC between on day 21; if
negative, discharge from KA program and refer for further medical investigation.
If TOC is positive, continue with SSG until getting a negative TOC, up to a maximum of 60
days (SSG60). The TOC is repeated weekly; once you have a negative TOC, stop treatment.
If symptoms are still persisting, refer for further medical investigation.
If TOC after 60 days of SSG treatment is still positive: contact KA Adviser to decide on a new
treatment regimen.
NB: Dates of the planned Tests of Cure should be written on the patient card!

• Severe cases: see 15.3.

• HIV positive patients: see 8.4.1.

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8.2.2. First Relapse Kala Azar
Provider Initiated Counselling and Testing - PICT (also if tested negative before)

• HIV negative (tested) patients or patients who refuse HIV testing:

Assess severity – see 15.

If severity score is <5:
Paromomycin for 17 days and SSG for at least 30, up to a maximum of 60 days
(PM17/SSG30–60).

TOC is done on day 23 and 30. If both tests are negative and the patient is well: discharge.
If one of the TOCs is positive, continue treatment and repeat TOC weekly until two
consecutive tests are negative.
If TOC remains positive after completion of 60 days of SSG, and/or the patient remains
unwell, contact KA adviser and start with AmBisome 5 mg/kg/dose twice weekly (e.g.
Tuesday and Friday) for at least 2 weeks and up to a maximum of 8 weeks. Repeat TOC
weekly; continue treatment until two consecutive TOCs are negative.
If TOC remains positive after 8 weeks of AmBisome, contact KA adviser again.
NB: Dates of the planned Tests of Cure should be written on the patient’s card!

• HIV positive patients: see 8.4.2.

8.2.3. Second and Third Relapse Kala Azar

Contact KA adviser. Choice of drug combination and length of treatment for multiple
relapse patients will depend on previous treatments and response.

In relapsed patients, try as much as possible to exclude HIV and TB; in the presence of these
diseases, cure of KA may be impossible. TB may not be clinically obvious, but is a common
cause of frequent relapses or inability to cure – you may need to treat TB empirically.
HIV positive patients must start ART.
See algorithm in Annex 3.

8.2.4. PKDL/PKMDL
Patients should also be assessed for severity (like KA patients) and tested for HIV, to decide
whether they should avoid SSG treatment. However, such cases are rare; if you find one,
contact KA adviser for advice.
Otherwise, treat with PM17/SSG30; if needed, SSG treatment can be extended up to
60 days.
Stop treatment when there is clear improvement of the PKDL rash; there is no need to
continue until the skin rash has completely healed. No TOC necessary.
If the patient shows no improvement, contact KA adviser.

8.2.5. Pregnant and lactating women

Pregnant women with KA have an increased risk of spontaneous abortion, still birth, and
premature birth as compared to non-KA pregnant women. Pregnant women with KA are also
more at risk of death because of severe anaemia and decreased immunity. During and after
delivery the anaemia and higher bleeding tendency (low platelet count) may result in fatal
haemorrhagic complications. Blood transfusions may be indicated more frequently.

During pregnancy and lactation, immunity is decreased, which may reduce treatment
response and inhibit an effective cell-mediated immunity after treatment. However, clinical
assessment of cure in pregnant women is hampered because the spleen cannot be palpated,
and because weight loss is difficult to measure. Therefore, a test of cure is indicated during
pregnancy and the first 6 months of lactation. It has to be taken into account that during

17
the second and third trimester of pregnancy a spleen aspirate is not possible, and one has to
rely on (less sensitive) lymph node aspiration for TOC.

Because of the harmful effects of most KA drugs in pregnancy, routine pregnancy testing
should be done before treatment initiation. If no test is available, check if you can find out
whether the woman might be pregnant: physical examination, first day of last menstruation.

AmBisome is the drug of choice in pregnancy as it is the safest option. SSG has proven to be
toxic, resulting in high incidence of spontaneous abortion as well as premature delivery.
Paromomycin can cause ototoxicity in the foetus. Miltefosine is potentially teratogenic and
should never be used during pregnancy.

Vertical mother-to-child transmission resulting in congenital KA in the infant has been

reported. Therefore, following up infants born from mothers diagnosed with KA might
increase diagnosis and prevent avoidable deaths in infants.

There is vertical transmission of antibodies from the mother to the infant. Therefore an
infant of a mother who had KA during pregnancy will be serologically positive (IT Leish,
DAT), even if it does not have KA itself. However, an infant who is symptomatic of KA, has a
positive serology, and a mother who had KA during pregnancy, is very likely to have KA, and
should be started on treatment.

8.2.6. Jaundiced patients

Patients who have jaundice (yellow eyes) should always be referred directly to a senior
medical person; these patients are very sick, and have a high risk of dying. The senior medic
will confirm the jaundice, and testing will be done to prove whether they really have KA.
If the Kala Azar test turns out positive, the patient is treated with full course AmBisome.

8.3. Treatment of Kala Azar in HIV positive patients

8.3.1. Primary Kala Azar in HIV positive patients

Baseline parasite load will be determined by aspirate before start of treatment.

Treatment: AmBisome 5 mg/kg/dose x 6 doses over 12 days + Miltefosine x 28 days.

In projects which offer Anti-Retroviral Therapy, the patient should start ART.
Women in childbearing age must start effective contraception (preferably Depo Provera) due
to the contra-indication of Miltefosine during pregnancy. Because Miltefosine remains in the
body for a long time after treatment, contraception should be given during treatment and
for three months after.

TOC is done on day 28; if negative, the patient can be discharged.

If it shows no or no significant parasite reduction (≤1 grade), start the patient on
PM17/SSG17-30. TOC 2 will then be done on day 45 (after 17 days PM/SSG); if negative:
discharge; if positive: continue with SSG up to 30 days and repeat TOC on day 58 (SSG30); if
negative: discharge; if positive: contact KA adviser.
If TOC on day 28 shows significant parasite reduction (≥2 grades), the patient will have
another full course AmBisome 5 mg/kg/dose x 6 doses over 12 days + Miltefosine x 28 days.
TOC 2 will be done on day 56 (after the second course); if negative: discharge; if positive:
start with PM17/SSG17-30. TOC 3 will then be done on day 73 (after 17 days PM/SSG); if
negative: discharge; if positive: do TOC 4 on day 86 (SSG30); if negative: discharge; if
positive: contact KA adviser.

NB: Put extra emphasis on hydration to reduce the risk of SSG toxicity - the patient should
drink plenty of water, and must be monitored for signs of dehydration.

18
8.3.2. First Relapse Kala Azar in HIV positive patients

Baseline parasite load must be determined by aspirate before start of treatment.

Treatment: AmBisome 5 mg/kg/dose x 6 doses over 12 days + Miltefosine x 28 days;

start ART.
ONLY in case of complete clinical and parasitological unresponsiveness to
AmBisome+Miltefosine combination therapy during Primary Kala Azar treatment,
relapse treatment will be initiated with PM17/SSG30-60.

TOC 1 will be performed on day 28 and TOC 2 on day 35; if both negative: discharge.
If TOC positive and no or no significant parasite reduction (≤1 grade): PM17/SSG30-60;
perform TOC weekly after day 23 of SSG; if 2 consecutive TOCs are negative: discharge;
if TOC on day 60 of SSG is still positive: contact KA adviser.
If TOC positive, but significant parasite reduction (≥2 grades): AmBisome 5 mg/kg/dose x 6
doses over 12 days + Miltefosine x 28 days; perform TOC on day 28 and day 35 of the second
course of AmBisome/Miltefosine. If both negative: discharge. If positive:
start PM17/SSG30-60; from day 23 of SSG start performing TOCs weekly - if negative for two
consecutive weeks: discharge; if positive on day 60 of SSG: contact KA adviser.

19
 8.4. Summary table: Treatment of Leishmaniasis

Situation Treatment regimen TOC

Do only if patient
Primary KA PM17/SSG17 still appears clinically sick on
day 21
First TOC is positive on day
Continue treatment with SSG up to 60 21.
Primary KA,
days Continue SSG and repeat
slow responder
TOC weekly until test is
(TOC positive after
Consider TB negative;
PM17/SSG17)
if still positive after 60 days
SSG: contact KA adviser
AmBisome 5 mg/kg/dose x 6 doses over
Baseline parasite load.
12 days
TOC on day 28.
Primary KA, plus
If negative, discharge;
HIV positive Miltefosine x 28 days
if positive: see algorithm
Start ART (if possible)
TOC on day 23 and 30.
If both test are negative,
PM17/SSG30-60
discharge; if positive,
First Relapse
continue once per week until
Consider TB
two consecutive tests are
negative; if positive after 60
days SSG: see algorithm
AmBisome 5 mg/kg/dose x 6 doses over
Baseline parasite load.
12 days
First Relapse, TOC on day 28.
plus
HIV positive If negative, discharge;
Miltefosine x 28 days
if positive: see algorithm
Start ART. Consider TB
Choice and length of combination 2 consecutive negative TOCs,
therapy depending on previous one week apart, are required
2nd, 3rd Relapse etc
treatment experiences: contact MedCo. before discharge:
Consider TB treatment contact KA adviser
AmBisome 5 mg/kg/dose x 6 doses over
Do only TOC if patient
12 days
SSG toxicity still appears clinically sick on
or
day 21
Continue PM/SSG after break
Pregnancy, and Do routine ToC on day 21,
AmBisome 5 mg/kg/dose x 6 doses over
until 6 months and if positive, repeat on day
12 days
post-partum 28?
AmBisome 5 mg/kg/dose x 6 doses over Do only if patient
Jaundice 12 days still appears clinically sick on
Check urine for Bilirubin day 21
Do only if patient
Severe KA AmBisome 5 mg/kg/dose x 6 doses over
still appears clinically sick on
(Primary + Relapse) 12 days
day 21
Not needed.
PKDL/PKMDL PM17/SSG30-60 If no improvement:
contact KA adviser

20
8.5. Daily routine
For all patients every day...

Take the TEMPERATURE

ASK THE PATIENT how he/she feels (not the

caretaker, if possible!)

LOOK FOR SIGNS OF DRUG SIDE EFFECTS (including

hearing problems when treated with PM) and
INTERCURRENT ILLNESS

LOOK FOR SIGNS OF DEHYDRATION and encourage

fluid intake

8.5.1. Clinical assessment

Ask the patient how he/she feels and note it on the card. It is very important to document
every day so that there is a treatment record; thus you can see whether the patient is
improving, and how fast.

8.5.2. Ferrous fumarate 185 mg (=60 mg elemental iron) + Folic acid 0.4 mg tabs

Give Ferrous fumarate 185 mg + Folic acid 0.4 mg daily to all KA patients except to severely
malnourished children (MUAC <125mm, W/H <-3 Z-score and/or bilateral oedema) as for
them, the iron can be dangerous!
Otherwise give:
• ½ tablet (30 mg elemental iron) to children less than 15 kg
• 1 tablet (60 mg elemental iron) to patients of 15 - 35 kg
• 2-3 tablets (120-180 elemental iron) to patients above 35 kg

8.5.3. Folic acid 5 mg tablets

Give 2 tablets of Folic acid 5 mg daily to all KA patients, adults and children.

8.5.4. High-energy food

Besides the regular food from the WFP-ration, patients should get additional 1000 kcal/day
in form of specialized food such as PlumpyNut, F100 milk or BP 5 biscuits. Depending on
what is available, the same should be given to all patients during treatment. Observed
nutrition is the ideal, i.e. one of the sachets of PPN can be given while the patient is waiting
for consultation, so the consultant has a better idea of appetite.

Amount of kilocalories per food item:

Item BP 5 PlumpyNut F100
Quantity 1 bar 1 sachet 500 ml (=1 cup)
Kcal 250 500 500

21
Tell the patient and the relative that it is very important that the patient gets this as it is
medicine for him/her, and will help to make his/her body strong to fight Kala Azar.

Malnourished adults should receive additional 2000 kcal/day; children must be admitted to
a Therapeutic Feeding Program (TFP).

8.6. Weekly activities

8.6.1. Chart review

Do a chart review once a week on a fixed day to see the patient’s progress (size of spleen,
weight gain etc) and to check for possible mistakes in calculations of drug dosages, BMI etc.
Also make sure that the daily documentation is complete and correct, and done with
diligence.

8.6.2. Weight

Weigh the patient every week and recalculate the dosage of the Kala Azar medication; it is
very important that the patient gets the correct dose.
Weight gain is also a sign of treatment progress.

8.6.3. Weekly food distribution

Usually, this comes from WFP; each patient receives a ration which also includes an amount
for the caretaker.

8.6.4. Distribution of soap

Each patient receives one piece of soap per week.

22
9. PATIENT EDUCATION

Health Education prevents people from becoming sick or helps them to get
healthy again quickly.
It is just as important as treating the disease!
Teach the patient how to avoid getting Kala Azar so they can protect themselves
and their family members.
Teach the patients how to prevent intercurrent illnesses while they are receiving
KA treatment.

9.1. Bed nets

Each patient is given a bed net on admission; they can take it home on discharge.
Make sure that they are using it correctly, and continue to do so after the treatment has
finished. This will prevent the spread of the parasites to sand flies while they are sick, and
it will help them not to get Kala Azar (and Malaria as well) in the future.

9.2. Water
Ensure that clean water is always available in the clinic compound for the patients to use at
any time; clean water will significantly reduce the risk of diarrhoea.
Patients must drink plenty of water – more than usual - during treatment for KA, as drug
side effects and toxicity are worse in dehydration, resulting in an increased risk of death.
Advise adults to drink at least 6 large cups of water a day; advise children to drink at least 3
- 4 large cups of water a day.
Make sure that the daily oral medication is taken with clean water as well.

9.3. Latrines
Advise people to use latrines, and teach them how to use them properly, including hand
washing. This will prevent diarrhoea-causing germs from being passed from one patient to
another.

9.4. Personal hygiene

Soap is given during the weekly distribution and should be used by patients and caretakers.
It will help stop skin infections and transmission of various infections transmitted by contact
such as common colds, diarrhoeal diseases, etc.
Teach patients and caretakers to keep themselves and their children clean. Explain to the
mothers that dirty faces attract flies, and flies cause diseases, including diarrhoea and
conjunctivitis.

9.5. Coughing
Anybody that has a cough should cover the mouth with his/her hand and spit out the sputum
in a safe place – ideally, a container (e.g. empty drug containers) should be used. That helps
to stop cough-causing germs from infecting other persons.

23
10. DRUGS USED TO TREAT KALA AZAR

10.1. Sodium Stibogluconate (SSG)

10.1.1. General information

SSG comes in 30ml vials containing 100 mg/ml and is given IM.
Store in a cool place and protect from sunlight.
The contents should not be used more than 1 month after removing the first dose – write the
date of opening on the vial.

10.1.2. Dosage

See Annex 2.

10.1.3. Side effects/contraindications

SSG can help cure patients with Kala Azar, but it can also sometimes cause harm to patients
if side effects occur. It is contraindicated in pregnant women.
Patients should be daily asked for presence of side effects (vomiting, abdominal pain,
diarrhoea).
Possible side effects include:

• Vomiting
This is common and can be very severe, leading to dehydration and even death.
Make sure you ASK EVERY PATIENT EVERY DAY whether they have been vomiting. If
necessary, give Metoclopramide (see Annex 2 for dosage). It is very important to monitor
patients that are vomiting very closely for signs and symptoms of SSG toxicity. ALWAYS
advise your patients to drink a lot of water during treatment.

• Cramping
Abdominal cramps are common in Kala Azar patients. Sometimes it is caused by SSG. Check
that it is not due to worms or diarrhoea.

• Painful injection site

Check for injection abscess. If there is an injection abscess inject in another site and treat
the abscess according to protocol.

• Joint pain
Give Paracetamol to ease the pain.

• Heart problems
SSG can make the heart have an unusual beat. It may suddenly stop, causing the patient to
die. This is extremely rare but is a greater risk if the patient is dehydrated. ALWAYS
encourage the patient to DRINK PLENTY OF WATER.

• Neurological problems
This means problems with the nerves. Some patients can get a tremor (shaking) in their
limbs, or are unstable when they stand up. Explain to the patient that this is due to the
treatment and will stop when they finish their treatment.

• Kidney impairment
Ask the patient if they passed urine in the last 8 hours and check for the quantity and colour
(dark yellow urine is concentrated and the patient should be encouraged to drink more).

24
10.1.4. SSG toxicity

SSG toxicity means that the patient becomes severely ill due to SSG. It is rare, but it can
cause death!
Signs and symptoms of SSG toxicity:

• The patient becomes confused or develops tremor or convulsions while on SSG

treatment
• Severe vomiting that does not improve with Metoclopramide
• Severe abdominal pain - when the abdomen is examined there is generalized
peritonitis suggesting pancreatitis

What to do if you suspect SSG toxicity

• If possible call the doctor or senior nurse

• Stop SSG (and PM) for 2-5 days
• Re-hydrate the patient so they pass urine at least 5 times per day
• Give Metoclopramide for vomiting
• If the symptoms improve, reintroduce SSG/PM at usual dose:
o If the SSG/PM treatment is interrupted for less than 5 days, continue the
treatment until day 17 (the patient will receive the full 17 doses)
o If SSG/PM is interrupted for more than 5 days, restart SSG/PM from day 0 and
give full course (17 days of SSG/PM) in the PHCU
• In PHCC, if the vomiting/toxicity signs continue for more than 5 days without
SSG/PM, start AmBisome

10.2. Paromomycin (PM)

10.2.1. General information

Paromomycin (PM) comes in 2ml ampoules containing 500 mg/ml Paromomycin sulphate
(equivalent to 375 mg/ml Paromomycin base) and is given IM.

10.2.2. Dosage

See Annex 2.

10.2.3. Contraindications

PM is contraindicated in pregnant women. It can cause ear and kidney damage to the baby.

PM is also contraindicated in patients with hearing problems

10.2.4. Side effects

Deafness & ringing in the ears:

Before initiating treatment a hearing test should be done (e.g. with the whispering test, at
50 cm distance from the back, and/or a tuning-fork), and paromomycin should be withheld
in patients with impaired hearing.

25
Stop paromomycin in case of complaints of hearing loss & ringing in the ears during
treatment. This should be checked daily during treatment, and a hearing test should be
performed in case of suspicion.
If the planned schedule was PM17/SSG17 (PKA), extend SSG treatment to 30 days. If the
planned schedule was PM17/SSG30 (relapse), extend SSG treatment to at least 40 days.

10.3. AmBisome
10.3.1. General information

AmBisome (also known as liposomal Amphotericin B) comes in 50 mg powder vials. It needs

cold chain during transportation, and cool storage (<25oC). It is dissolved with 12ml water
for injection; the concentration is then 4 mg/ml. The filter (supplied together with the
AmBisome) should always be used before administration. It is given as an infusion over 2-4
hours in Dextrose 5%.

10.3.2. Full course AmBisome (Hospital/PHCC only)

a. What is full course AmBisome?

“Full course” means that AmBisome 5mg/kg/dose is given every second day until 6 doses
are completed.

b. Who gets full course AmBisome?

• Patients intolerant of SSG

• Severe KA (score ≥ 5)
• Pregnant women, irrespective of severity of KA
• Patients ≥ 45 years of age, irrespective of severity of KA
• HIV co-infected patients: in combination with Miltefosine daily for 28 days.
• Primary non-responders: Patients who are unresponsive to first line treatment.
This is defined as no decrease in the grade of parasite load after adequate
treatment; for those patients who were not aspirated on admission, we use 4+ in TOC
as definition for primary unresponsiveness.
• Jaundiced patients
• Children <2 years, in case proper daily patient monitoring in the OPD cannot be
guaranteed

In severely ill KA patients initiation of treatment is urgent in order to reduce parasitaemia

and further deterioration. Therefore AmBisome treatment should be started immediately
after admission, even is this in the afternoon or evening.

10.3.3. Dosage

See Annex 2.

10.3.4. Side effects

There are few serious side effects associated with AmBisome.

However. before starting the first dose a small test dose should be given to rule out the risk
of AmBisome allergy (which can give anaphylactic reactions). A test infusion of 1 mg is

26
administered for about 10 minutes, after which the patient is observed carefully during half
an hour. If no severe allergic reaction has occurred the infusion can be continued.

Some patients complain of lower back ache if the infusion is running too fast – in this case
adjust the infusion to run more slowly.

Do not give together with diuretics (e.g. Furosemide), because that may cause severe
hypokalaemia.

10.4 Miltefosine
10.4.1 General information

Miltefosine comes in 10 mg or 50 mg capsules. It should be taken with meals to reduce the

side effects. Doses of 100 mg (2x 50 mg) can best be divided over two separate meals.

10.4.2 Dosage

See Annex 2.
Miltefosine will, in principle, only be used if a patient with KA is also HIV positive.
However, in occasional cases Miltefosine can also be used ex-protocol in patients who did
not respond to AmBisome treatment, but in whom SSG is contra-indicated (e.g. elderly).

In children the linear dosing (per kg body weight) is inadequate for effective cure, and
dosing should be based on body surface (allometric dosing). In these cases contact the KA
adviser.

10.4.3 Contraindications

Miltefosine is contraindicated in pregnancy and during lactation. It is potentially harmful

for the fetus. Women in childbearing age who are not pregnant must use an effective
contraceptive (Depo Provera). Because Miltefosine can cause vomiting, oral contraceptives
are not recommended. Because Miltefosine remains in the body for a long time after
treatment, contraception should cover the treatment period plus 3 months after.

Miltefosine is contraindicated in case of pre-existing severe damage of the liver (jaundice)

or impaired kidney function.

10.4.4 Side effects

Miltefosine is well tolerated most of the time, but frequently causes transient nausea with
mild to moderate vomiting and diarrhoea may occur, which will disappear after some days.
Rarer side effects include anorexia and abdominal pain.

27
11. INJECTIONS

11.1. Preparations
• Collect and prepare all the materials you need.

• Always make sure you use a new, sterile needle and syringe for every injection.

• Make sure you keep everything very clean.

• Draw up the correct amount of medication for the patient; check again with the card
after you have drawn it up to make sure that you didn’t make a mistake.

• Inject the patient in a different area every day. You can use the buttocks and the
thigh to give the injection.

• If the patient complains of pain and swelling at an old injection site, check for an
injection abscess.

11.2. Practical execution

• Put on gloves.

• Choose the correct site for giving the injection. Use the upper outer buttock or the
thigh to give the injection. Give the injection ALWAYS in the thigh for babies.

• Clean the site with iodine.

• Give the injection.

• Use clean cotton wool or gauze to wipe the site after injecting.

• Put the needle in the sharps box straight away after the injection (do not recap!).

• Use a separate needle for every injection.

• NEVER give SSG and Paromomycin at the same injection site.

• For volumes of 10 ml or more, split the dose in two syringes and inject in two
different sites.

• SSG injections that are given forcefully (<1 sec/ml) are unnecessarily painful, and
can cause tissue damage and abscesses. Injections should be given slow (>2 sec/ml)

28
29
12. INTERCURRENT ILLNESSES
! IT IS VERY IMPORTANT TO TREAT INTERCURRENT ILLNESSES.
IT IS THESE ILLNESSES WHICH CAN KILL THE PATIENT !

12.1. Diarrhoea
Patients will not die from the diarrhoea-causing germ, but they can die from dehydration.
It is very important to keep the patients well hydrated to prevent death.
Patients with diarrhoea must drink a lot!

Treatment

a. Dehydration – see 12.3. below

b. Drug treatment:
• Diarrhoea > 1 day, diarrhoea with fever, bloody diarrhoea and severe diarrhoea:
Treatment: Ciprofloxacin or Tinidazole (see Annex 2 for dosage).
If diarrhoea continues on day 3, continue Ciprofloxacin up to day 5, for a maximum
of 10 days.
• For children below 8 kg, use Metronidazole only (see Annex 2 for dosage).

12.2. Vomiting
In a Kala Azar patient, vomiting can be due to different causes:
• SSG toxicity
• Miltefosine side effects
• Diarrhoeal illness
• Excessive coughing
• Tinidazole or Metronidazole can also cause nausea/vomiting as a side effect

As with diarrhoea, patients with vomiting are at risk of dehydration. Vomiting must be
treated straight away as patients can die from dehydration.
The patient must replace the water that their body is losing through the vomiting.

Treatment

a. Medical advice
Advise patients with mild vomiting to eat several small meals rather than one big meal, and
to drink small amounts frequently. Do not let children drink a lot at once, as they will vomit
again.

b. Dehydration - see 12.3. below

c. Drugs
If the patient is vomiting only after coughing, do not give medicine. Encourage the patient
to drink more. If the vomiting is not from coughing, give Metoclopramide tablets first.
Advise the patient to wait 1 hour before taking other medicine or eating.

d. SSG toxicity
If the patient has continuous vomiting and no expat is on ground, stop SSG for 2-5 days and
see 10.1.3. (SSG side effects).

30
12.3. Dehydration
Dehydration can develop due to vomiting, diarrhoea or bleeding and is very dangerous in
Kala Azar patients. You can prevent this from happening! Ask how many times they have
vomited or had diarrhoea. Ask the patient how much they are drinking, and check urine
output. Always encourage fluid intake!

12.3.1. Diagnosis/grading

Mild Dehydration – the patient is thirsty but otherwise all right.

Moderate Dehydration – the patient is thirsty with rapid pulse, deep breathing, dry mouth,
dark and concentrated urine, slow skin pinch, mildly sunken eyes and a sunken fontanelle in
babies.

Severe Dehydration – the patient may be drowsy or unconscious, a weak and rapid pulse
(sometimes not palpable), cold and clammy hands, deep and rapid breathing, very slow skin
pinch, severely sunken eyes, urine production absent and a very sunken fontanelle in babies.

12.3.2. Treatment

a. Mild to moderate dehydration

• Give ORS: Mix 1 sachet with 2 cups of clean water (1 litre). Explain this carefully to
the patient.
• If the patient is a severely malnourished child (Z-core < -3) give half strength ORS (in
PHCU) or Resomal (in PHCC). Make half strength ORS by mixing 1 sachet of ORS with
4 cups of water.
• 50 ml per kg should be drunk in the first 4 hrs. Make sure the patient stays in the
clinic so this can be monitored.
• For children, make sure the mother knows how to give the ORS with a spoon or cup in
small amounts regularly. The mother should also continue breast-feeding.

b. Severe dehydration
• If patients are severely dehydrated, they probably need IV re-hydration.
• Ideally use Ringer’s lactate (RL).
• Give 20 ml/kg body weight every hour until the patient starts to improve - when they
become more awake or pass urine.
• Then give 10 ml/kg body weight every hour and closely monitor their condition. Once
they can take ORS, change to oral fluids.
• CHECK THE PATIENT EVERY HALF HOUR TO SEE IF THEY ARE GETTING BETTER OR
WORSE. IF YOU ARE CONCERNED CALL A SENIOR STAFF!
• If the patient is very severe and no one is trained to give IV fluids, naso-gastric (NG)
tubes can also be used to give fluid to someone who cannot drink. Insert a naso-
gastric tube (only if you are trained!) and check the correct position in the stomach.

31
12.4. Cough
A Kala Azar patient may have a cough for several reasons.

12.4.1. Kala Azar cough

This is a dry cough that occurs because of the Kala Azar parasites. Check the patient’s
temperature, count the respiratory rate and listen to the chest to make sure it is not
pneumonia. Increased water consumption has shown to improve KA cough.

12.4.2. Upper Respiratory Tract Infection (URTI)

This is an infection in the high chest or throat. The patient may have a sore throat and
runny nose. A common cold does not need any treatment; just encourage the patient to
drink more water.

12.4.3. Pneumonia

This is an infection of the lung and is very serious in a Kala Azar patient.

a. Signs & Symptoms

• Sputum( greenish) or new bloody sputum

• High fever
• Fast breathing (high respiratory rate)
• Chest pain
• Check for crackles (crepitations) in the lungs by using stethoscope (auscultation)

b. Treatment

• Mild & moderate pneumonia: Amoxicillin PO

• Severe pneumonia: Ceftriaxone IV for 3-5 days until improvement, then switch to
Amoxicillin PO

12.4.4. Tuberculosis (TB)

If the patient still has chest problems after two different courses of antibiotics, check for
TB. Ask the patient if there is a family history of TB and refer to TB program for further
investigation. Also consider the possibility of extra-pulmonary TB.

12.4.5. Aspiration pneumonia

This occurs when someone has a convulsion and vomits, and some of the vomit goes into the
lungs. Be careful when inserting naso-gastric tubes; wrong positioning (lungs instead of
stomach) might cause an aspiration pneumonia.
It is treated with Metronidazole and Amoxicillin (Ceftriaxone and Metronidazole in severe
cases).

32
12.5. Bleeding
Kala Azar patients have low platelets so their blood does not clot normally and they bleed
easily. They can die if they lose too much blood.

12.5.1. Bleeding of the gums

• If the patient has gum bleeding there is probably an infection in the mouth as well.
• Give Amoxicillin and consider Multivitamin tablets.
• Also encourage the patient to rinse their mouth with warm water after eating (teeth
brushing would be ideal).

12.5.2. Bloody diarrhoea

• Treat using the diarrhoea protocol.

12.5.3. Bleeding after childbirth or abortion

• If the bleeding is severe, the patient may need to be transferred to PHCC (preferably
a PHCC with surgical capacity).
• Seek advice of experienced staff.
• If the bleeding is not severe, give ORS; Metronidazole and Amoxicillin in case there is
an infection.

12.5.4. Nose bleeding

If the patient has nose bleeding, ask the patient to sit with their head forward (reading
position) and get them to pinch their nose at the bottom of the bony bit. It is important that
the patient or their caretaker holds the nose for a long time. If the bleeding goes on for
more than 30 minutes consider packing the nose.

How to pack a nose

• It is uncomfortable for the patient when you are packing the nose.
• Explain to the patient that it is very important to stop the nose bleeding.
• Use a nasal tampon if available. Insert one of these into the bleeding nostril. It will
automatically expand and stop the bleeding.
• If a nasal tampon is unavailable, use gauze soaked with 1 vial of Adrenaline and some
Vaseline (petroleum jelly) in a kidney dish. If you do not have Adrenaline, just use
Vaseline. The Vaseline helps the gauze to enter the nose smoothly.
• Make sure the gauze is not too wet, when using Vaseline wipe away the excess.
• Carefully put one end of the gauze into the nostril that is bleeding using a curved
blunt forceps.
• The gauze should be put right to the back of the nose because that is where the
blood is coming from.
• Tape the nose pack securely against the face.
• If the blood is coming from both nostrils, then pack both sides.
• To help putting the gauze right to the back of the nose, get the patient to sit with
their head against a wall.
• Check that you do not push the gauze too far by looking inside the mouth. If you can
see some bandage inside the mouth, you should remove it and start again.
• One day later the bandage can be removed; if the bleeding starts again, the nose
needs to be packed again.

33
12.6. Eye infection
a. Signs & Symptoms

Red, itchy eyes with pus discharge, especially in the morning after waking up.

b. Treatment

Teach the patient to wash their hands with soap and water before touching their eyes.
Teach them to clean the eye with clean water three times a day. If the problem does not
clear up, give some tetracycline eye ointment and advise the patient or caretaker to use it 4
times a day until 2 days after the infection has gone.

12.7. Ear infection

Otitis media is not a contraindication to continuation of PM. However, a careful exam and
discussion should be performed if otitis media also seems to have diminished hearing as a
symptom. Err on the side of caution if diminished hearing is present.

a. Signs & Symptoms

• Fever and headache

• Pain in the ears
• Pus from the ears
• Deafness
• In children: irritability - crying all the time.

b. Treatment

• Wash ears with soap.

• Give 7 days of Amoxicillin and check if the symptoms have improved.
• If they have not improved, continue the Amoxicillin for another 5 days.

12.8. Skin and wound infections

Any cut to the skin can become infected and may form a pocket of pus under the skin,
called an abscess.

a. Signs & Symptoms

• Hot, red shiny skin

• Pus from wound
• Round lump that feels like it is full of fluid
• Fever
• Pain

b. Treatment

• An abscess must be opened and drained.

• Small abscesses can be drained with a syringe or may need to be cut with a sterile
blade. See a senior staff for help.
• Do dressings every day after the abscess is drained.
• Give Metronidazole and Cloxacillin.
• In skin infections where there is no abscess, the patients need a treatment with
Cloxacillin. These wounds also need to be cleaned and a dressing applied daily. Give

34
 Paracetamol if the patient is complaining of pain. (Do not give Ibuprofen or Aspirin
as these drugs can increase the risk of bleeding in KA patients!)

12.9. Malaria
a. Signs & Symptoms

• High fever
• Joint and muscle pains
• Headache
• Fast breathing
• Convulsions/unconsciousness

b. Treatment

• Do a RDT (SD Bioline) or blood film to confirm Malaria.

• If positive: treat according to guidelines (AS/AQ PO, or Artesunate IV for severe
cases).
• If the patient has a history of convulsions, you must observe him/her closely and
consider Diazepam. Discuss with senior medical staff.

REMEMBER: Severe (cerebral) Malaria looks just like Meningitis, so make sure you treat for
Meningitis if the RDT is negative, or there is no response to antimalarial treatment. Use
Ceftriaxone to treat Meningitis.

12.10. PKMDL Iritis

If the eyes are affected they need special treatment. Tell the patient to wash the eyes
twice a day – give Normal Saline and gauze, otherwise advise to clean with boiled and
cooled water. They may need Tetracycline eye ointment if the eyes are super-infected.
If the infection is severe, refer to a doctor or contact MedCo.

12.11. TB co-infection
In patients who have both KA and TB, it is very difficult to cure KA, if TB is not treated at
the same time. Therefore both diseases must be treated simultaneously.
Keep in mind that TB can present extra-pulmonary as well. Taking a proper history is
essential.

12.12. HIV co-infection

When a person has both HIV and KA, it is very serious. HIV infection makes KA worse, and KA
makes HIV worse. It is difficult to cure a patient of KA if he/she is infected with HIV,
because they fail to generate an effective cellular immunity against KA, and therefore easily
relapse. If available, start antiretroviral therapy (ART) in co-infected patients. This
treatment will help to improve the immune system and reduce the risk of KA relapse and
other opportunistic infections.
Co-infected patients also receive a different KA treatment regimen.

12.13 Hypoglygaemia
Fatal hypoglycaemia occurs regularly in young children and pregnant women. While adrenal
failure can contribute to hypogylcaemia, it is generally attributed to a liver problem (loss of
liver glycogen). The main intervention should be by giving feed and/or IV glucose. The main

35
feature of adrenal failure is circulatory collapse (shock) rather than low blood glucose.
Steroids are recommended if the patient has signs of dehydration / circulatory collapse
(cold peripheries, slow capillary refill, low BP, fall in BP on standing) or if the patient looks
critically ill. Hydrocortisone IV 100mg 8 hrly for a large adult, or 2-4 mg dexamethasone IV 8
hourly. Use lower doses for smaller individuals. Steroid treatment can be discontinued once
the patient improves, as it is not likely that the adrenal failure persists.

13. DISCHARGE PROCEDURE

At the end of the treatment you need to decide whether the patient is cured from Kala Azar
or needs more treatment.

Advise patients to come back if symptoms return, or they

develop a severe skin rash.
Patients should bring their discharge card when they return.

13.1. Clinical cure/Test of Cure (TOC)

Clinical response evaluation:
Signs of response are absence of fever, reduction in spleen and liver size, restored appetite,
and feeling well.
Important other elements which may not be present by the end of treatment, because they
will take longer: weight gain and increase of Hb. Knowing the patient and their individual
progress is key assessing clinical response.

TOC:
A spleen or lymph node aspirate, which is examined in the lab under the microscope for
parasites. If possible, do a spleen aspirate instead of a lymph node aspirate, as this is much
more sensitive.

Timing of ToC:
Because it takes time for the parasite load to become undetectable as a response to
treatment, an aspirate may still be positive at the end of treatment (day 12 for AmBisome,
or day 17 for SSG/PM), even in patients who respond well to treatment. Patients with very
high initial parasite load, and slow responders can have detectable parasitaemia for a longer
period. In the great majority of patients the cellular immunity will deal with the remaining
parasites, and eventually parasites are no longer detectable. This is general considered to
be around 28 days after starting effective treatment. It is therefore recommended to do a
ToC at day 28. However, if it is not possible to keep patients for such a long period, a ToC
can be done at day 21. It does not make sense to do a test-of-cure before day 21, as a
positive ToC at that time does not say anything about cure or failure.

AmBisome has a very long tissue half-life (~14 days), and is therefore still active long after
the last dose is given. Therefore, many patients who are still symptomatic on day 12 may
show good clinical response in the following days.

36
Patients requiring a ToC:
1. Primary KA (HIV-neg):
– If the patient improved well under treatment, he/she can be discharged without
TOC.
– Do a TOC only if the patient is still symptomatic at day 21. Even if the patient
was not well on the last day of treatment (which is more likely for patients
admitted with severe KA disease), if he/she shows good clinical recovery before
day 21 the patient can be discharged without ToC.

2. Primary KA (HIV-pos):
– Continue treatment until ToC is negative

3. Relapse KA:
– Two consecutive TOCs have to be negative before discharge.

4. Pregnant women, and until 6 months post-partum:

– Pregnancy (esp. late pregnancy and persisting into the post-partum period) is a
major immunosuppressive or immuno-modifying condition, which may hamper
the development of an effective cell-mediated immunity. ToC should be routine
on day 21 in patients who are pregnant, or who are <6 months post-partum

What to do with a negative TOC in a patient who is still symptomatic at the end of
treatment:
If splenic aspirate:
– patient can be discharged from KA treatment
If lymph node aspirate:
– in case of doubt, do a second LN aspirate (increased sensitivity), or
– observe patient for a week, and repeat LN aspirate one week later if still
symptomatic.

However, discharge from KA treatment does not mean that the patient should be sent home
if he/she is not well or still symptomatic. In this case one should look for differential
diagnosis.

Table: different patient categories, treatment regimens, and ToC protocols

Patient Treatment regimen ToC protocol

group
Primary KA, PM17/SSG17 ToC only if still symptomatic after Rx
HIV-negative on d.21, and if pos, repeat on d.28
Primary KA, AmBisome 30mg/kg (5mg/kg/d ToC on d.28; Continue treatment with
HIV-positive x 6) plus Miltefosine x 28 d AmBisome + miltefosine until ToC-neg
Relapse KA, PM17/SSG30-60 Discharge after two neg ToC on d.23
HIV-negative and d.30
Relapse KA, AmBisome 30mg/kg (5mg/kg/d ToC on d.28; Continue treatment with
HIV-positive x 6) plus Miltefosine x 28 d AmBisome + mltefosine until ToC-neg
Pregnancy + AmBisome 30mg/kg (5mg/kg/d ToC on d.21, and if positive, repeat
lactating <6M x 6) on day 28
Severe KA AmBisome 30mg/kg (5mg/kg/d x ToC only if still symptomatic after Rx;
6) d.21
SSG toxicity AmBisome 30mg/kg (5mg/kg/d ToC only if still symptomatic after
x 6) completing Rx; (≥d.21)
PKDL PM17/SSG30-60 ToC not done

37
13.2. Extended treatment in patients failing treatment
Patients failing SSG+PM treatment will continue with daily SSG injections with weekly ToC,
until the ToC becomes negative, and up to a maximum of total 60 doses of SSG. If the
patient still fails treatment after 60 doses, consult the KA adviser in Amsterdam.

Patients failing a full course of AmBisome treatment (6 doses) will continue with two doses
of AmBisome per week with weekly ToC, until the ToC becomes negative, and up to a
maximum of total 12 doses of AmBisome. If the patient still fails treatment after 12 doses,
consult the KA adviser in Amsterdam

13.3. Examination and recording on the patient card

a. Treatment end date
b. Outcome of treatment:
i. Discharge with negative TOC
ii. Discharge with clinical cure
iii. Default
iv. Death
c. Discharge weight
d. Discharge BMI or Z-score
e. Discharge Hb
f. Discharge spleen and liver size
g. Test of Cure, if applicable - dates, number of TOCs and results

13.4. Discharge drugs

• Give 30 ferrous/folic tablets (one tab per day for 30 days); if a child weighs less than
10 kg, cut 15 ferrous/folic tablets in half (half tab per day for 30 days).
If the patient is pregnant, give 60 tablets (one tab twice a day for 30 days).
• Repeat the Measles vaccination for patients below 16 years of age, if there was a
minimum time of 4 weeks between admission and discharge.

13.5. Discharge card

• All discharged patients receive a discharge card, which they must bring to the
health center if they develop again symptoms of KA or severe PKDL.
• Record on the card:
a. Place of treatment
b. Name and patient number
c. Age
d. Sex
e. Place of residence (county/payam/village)
f. Dates of admission and discharge
g. Final diagnosis
h. Type of test done for confirmation
i. TB co-infection yes/no
j. VCT code
k. Treatment regimen
l. Outcome:

38
 Discharge with negative TOC
Discharge with clinical cure
m. Spleen and liver size on discharge
n. Lymphadenopathy on discharge
o. Weight on discharge
p. BMI or Z-score on discharge
q. Hb on discharge

14. DEFAULTING PROCEDURE

What to do if a patient defaults:

• Trace the defaulted patient and try to get him/ her back in the program.
• Treatment after interruption:
o If the treatment is interrupted for less than 5 days, resume treatment on the
day he stopped.
o If the treatment is interrupted between 5 and 15 days, resume treatment at
the day it was stopped, and do a Test of Cure at the end of treatment.
o If the treatment is interrupted for more than 15 days, do a spleen or lymph
node aspirate when the patient returns. If the result is positive, restart the
treatment at day 0, and do a Test of Cure at the end of treatment; if the
aspirate result is negative, resume treatment at the day the treatment was
interrupted, and do a Test of Cure at the end of treatment.
• If the patient defaults for more than 2 months, treat as a relapse case.

39
15. SEVERE KALA AZAR
• Patients with increased risk of death from Kala Azar can be identified by a scoring
system; they must receive special treatment. The scoring system uses the patient’s
nutritional status, age, Hb and level of weakness to assess the risk of death.
• If a patient scores 5 or above according to the tables below, he/she is at more than
20% risk of death and is therefore eligible to special treatment.
• Seriously ill KA patients are often intolerant of SSG; whereas AmBisome is the least
toxic and most rapidly acting KA drug. AmBisome has >2 weeks half-life in spleen,
liver and bone marrow.
• If a severely ill patient is diagnosed with KA, the doctor or a senior KA nurse should
be called in order to decide on the treatment regimen.
• Missed patients:
If a patient within 1-3 days of starting PM17/SSG17 treatment is noticed to be
severely ill, but was not categorized as severe KA on admission, he/she can be re-
scored and, if necessary, changed to AmBisome treatment.

15.1. Scoring the patient

• Check age of the patient
• Check BMI for patients from 19 years of age onwards, or Z-score for patients below
19 years
• Check Haemoglobin level (Hb)*
• Assess the patient’s level of weakness
• Use the tables below to determine the score for each variable
• Add up scores
• Fill in the severity scoring table on the treatment card

* admission Hb may be overestimated because of dehydration; this will show as a

drop in Hb during the first days after admission when the patient is re-hydrated.
Therefore, Hb should be repeated on day 2-5 in order to be able to evaluate Hb
response to treatment. This may also prompt a re-evaluation of the severity
score.

Severity scoring charts

Age group 19 years and above: Adults

BMI Age Hb

Cut-off Score Cut-off Score Cut-off Score

over 16 0 below 30 yrs 0 over 8 g/dl 0

14 - 16 1 30 – 39 yrs 1 6 – 8 g/dl 1

13 – 13.9 2 40 – 44 yrs 3 4 – 6 g/dl 2

45 yrs
12 – 12.9 3 5 below 4 g/dl 4
and above

below 12 4

40
 Age group below 19 years: Children & Adolescents

W/H Z-score Age Hb

Cut-off Score Cut-off Score Cut-off Score

-2 and above 0 above 5 yrs 0 over 8 g/dl 0

<-2 1 2 – 5 yrs 1 6 – 8 g/dl 1

<-3 2 1 – 2 yrs 3 4 – 6 g/dl 2

<-4 3 below 1 yr 4 below 4 g/dl 4

Level of weakness
State of collapse = score 5
• Definition of collapse in adults/older children: unable to sit up unaided AND cannot
drink unaided
• Definition of collapse in babies: floppy when held in arms AND unable to feed
unaided

Severely weak = score 3

• Definition of severe weakness in adults/older children: cannot walk 5 m without
assistance
• Definition of severe weakness in babies: unable to sit upright unaided

Other types of weakness = score 0

15.2. Treatment of Severe Kala Azar

• Full course AmBisome: 5 mg/kg/dose x 6 doses over 12 days.
• Hydration.
• Nutrition: in case of severe malnutrition give therapeutic feeding according to
nutrition protocols. Otherwise give food supplement of 1000 kcal (2 sachets of
PlumpyNut/day).
• Antibiotics: treat any suspected infection aggressively with parenteral broad-
spectrum antibiotic treatment.
Give Ceftriaxone IV or IM: adults 1 g once daily; children 50 mg/kg once daily.
• Diarrhoea: treat diarrhoea aggressively with the appropriate drugs for amoebiasis,
giardiasis and bacterial causes.
• If the patient is in a state of collapse, give stress doses of corticosteroids:
Children: Hydrocortisone IV 5 mg/kg/injection (or Prednisolone PO 1 mg/kg STAT)
Adults: Hydrocortisone IV 100-500 mg/injection (or Prednisolone PO 50 mg STAT)
Hydrocortisone injections may be repeated up to 3x/day, if needed.
Treatment should be stopped as soon as the patient improves.
• Consider blood transfusion if Hb is less than 4g/dL or if there are signs of acute
respiratory distress.
• TOC is only needed if the patient still appears clinically sick at day 21 after starting
treatment.

41
 ANNEXES

Annex 1: Testing procedures

a. IT Leish test (rK39)

Introduction:
• The IT Leish test (“Kala Azar dipstick”) is a rapid diagnostic test to detect antibodies
of Kala Azar (rK39).
• The test is made with whole blood from a finger-prick.
• The result is obtained within 25 minutes to complete the full procedure:
Summary of the time needed
Procedure Time
Labelling strip, recording name in the
2 minutes
book, adding buffer in well 1 and 2
Wiping the finger and pricking 1 minute
Collecting blood into plastic pipette 1 minute
Strip with blood in well 1 (conjugated) 10 minutes
Strip with washing buffer in well 2 10 minutes
Interpreting and recording results 1 minute

Materials used:
- Dipstick strip
- Well cover
- Ampoule of buffer
- Gloves
- Lancet
- Disinfecting swab
- Cotton wool swab
- Sharps container
- Plastic pipette
- Registration book
- Pen
- Timer
Procedure:
- Tear open the aluminium package and take out all the materials.
- Arrange the materials on a clean flat surface.
- Label the strip (patient’s name or number and date).
- Record the details of the patient in the registration book.
- Add one drop of buffer to the first well (conjugate well).
- Add four drops of buffer to the second well (washing well).
- Allow to stand for one minute.
- Put on gloves.
- Clean the fingertip of the patient with the disinfecting swab.
- Leave it to dry.
- Prick the finger.
- Discard the lancet in the sharps container.
- Wipe the first drop away with dry cotton wool.
- Take the pipette.
- Squeeze the top of pipette and keep it squeezed.

42
 - Place the open tip into the drop of blood.
- Release pressure and draw up blood up to the black line.
- Add the entire volume of blood by squeezing the pipette gently to the first well
(conjugate well).
- Stir gently with upper end of the pipette.
- Discard the pipette into suitable waste container.
- Allow to stand for 1 minute.
- Pull out the dipstick holder with the label.
- Insert legs of the dipstick holder into the holes beside the conjugate well (first well).
- Allow to stand for 10 minutes.
- Transfer the dipstick to wash well (second well).
- Allow to stand for 10 minutes.
- Remove the dipstick from the wash well.
- Click it back into the clear plastic piece.
- Close the well with the well cover.
- Break them off.
- Break the two legs off from the clear plastic piece.
- Discard them into a suitable waste container.
- Read the reaction and interpret the results.
- Record the results in registration book.
- Keep the dipstick for future reference.

Interpretation of results
Valid results
Result Bands/marks Remarks
(i) Reaction field should be cleared of
blood
Positive Two pink bands are clearly seen
(ii) Indicates presence of antibodies
against L. donovani
(i) Reaction field should be cleared of
blood
Negative One pink band is clearly seen
(ii) Indicates absence of antibodies
against L. donovani

Invalid results
Problem Reaction field Possible cause Remarks
(i) No washing buffer added into
wash well
Dipstick not Reaction field
(ii) Wrong washing buffer used Repeat the test
sufficiently cleared remains red
(iii) Wind
(iv) Direct sunlight
1. Repeat to
confirm
(i) Strips exposed to extreme
Control band not 2. Report to lab
No mark seen heat.
present supervisor or
(ii) Expired strips
MedCo if the result
is the same

Important notes:
If the dipstick does not give a clear result, repeat the test.
Patients who have been treated for Kala Azar before CANNOT be tested with the
dipstick, as it will still give a positive result for many months or even years after
treatment, even if a patient currently does not have Kala Azar. If a suspect patient
was treated for Kala Azar before, send him/her to the PHCC for aspirate microscopy.

43
 Store the tests in a cool and dry place, below 30 degrees Centigrade.

b. DAT test
Introduction
A DAT (Direct Agglutination Test) is done on some drops of blood, which are taken from the
fingertip onto a piece of filter paper.
NB: Patients who have been treated for Kala Azar before CANNOT be tested with the DAT,
as it will still give a positive result for many years, even if a patient currently does not have
Kala Azar. If a suspect patient was treated for Kala Azar before, refer him/her for aspirate
microscopy.

Materials needed:
- Filter paper – “Whatman 3” - Other types of paper WILL NOT WORK!
- Gloves
- Lancet
- Disinfecting swab
- Cotton wool swab
- Sharps container
- Registration book
- Pen

Procedure:
- Label the paper properly with the patient name/number.
- Put on gloves.
- Clean the fingertip of the patient with the disinfecting swab.
- Leave it to dry.
- Prick the finger to produce a drop of blood.
- Discard the lancet in the sharps container.
- Collect the blood on the Whatman 3 filter paper. The blood must produce a spot
approximately 2 cm diameter on the paper. Do not let the finger touch the paper.
- The drop must also soak through the paper to the other side - check this.
- Put the filter paper in the box (separate from the other papers) and let it dry.
NB: Do not leave it in the sun – the sun destroys parts of the blood and the test will
not work well!
- The blood sample will last for 2 weeks. If you don’t have a lab, collect the samples
for the next transport.
- Fill in the registration book.

44
c. Lymph Node Aspirate
Introduction
A fluid sample is taken from a lymph node and examined under the microscope to see if
parasites for Kala Azar are (still) present. The lymph nodes which are usually used for
sampling are located in the groin area (inguinal LNs).
Always explain the procedure to the patient and family before beginning.

Materials needed:
- Gloves
- Sharps container
- 21G needle (green)
- 5ml syringe
- Clean microscope glass slide
- Gauze swab
- Cotton wool swab
- Disinfectant (alcohol or iodine)
- Diamond pencil
- Methanol
- Registration book
- Pen
- Slide box (if transport to the lab is needed)

Procedure:
- Label the slide with the patient’s lab number using a diamond pencil.
- Clean the slide with gauze or dry cotton wool.
- Rest the patient on the back with their legs stretched out. Another person can hold
down the patient if he/she is restless or agitated. If the patient is a small child, the
mother can hold the child on her legs.
- Put on gloves.
- Decide by palpation which inguinal lymph node is the largest one; this one will be
used for the procedure.
Note: The LNs that you puncture for aspiration don’t need to be greatly enlarged.
In South Sudan, LNAs are typically done on inguinal LNs around 1cm in diameter.
- Clean the skin over the LN with a cotton wool swab soaked in alcohol or Iodine and
let it dry.
- Hold the lymph node firmly between thumb and index finger and carefully insert the
21G needle. The insertion can be horizontal or at a slight angle to avoid hitting blood
vessels.
- Encourage lymph fluid to flow up the needle by twirling the needle whilst gently
“milking” the lymph node. For about 1 minute, continue massaging the LN and
twirling the needle while moving it a little in and out of the lymph node tissue. You
should see some pinkish fluid reaching the hub after about 1 minute.
- Withdraw the needle rapidly with your index finger sealing its hub.
- Put a gauze swab on the puncture site and ask the patient to press it on.
- Attach the 5ml syringe, containing a little air, to the needle and squirt the aspirate
onto the glass slide.
- Spread the sample material thinly along the slide (you can use the needle flat on the
slide to do this).
- Discard the needle in the sharps container.
- Allow the slide to dry on the air.
- Fix the specimen with methanol.
- Fill in the registration book.
- Hand the slide to the microscopist or store it safely in the slide box for transport.

45
d. Splenic Aspirate

Introduction
A tissue sample is taken from the spleen and examined under the microscope to see if
parasites for Kala Azar are (still) present. The aspirate can only be taken from a significantly
enlarged spleen.

A splenic aspiration should only be performed by a medical doctor or senior medical person
who has been trained and is experienced in the procedure.

Contra-indications:
Splenic aspiration should not be done if any of the following contra-indications are present:

• Spleen not or barely palpable (spleen size below 3 cm)

• Jaundice
• Signs of active bleeding (nose, skin, digestive tract, etc…). A minor nose bleeding is
not a contraindication
• Severe anemia (Hb < 5.5); in settings where there is no possibility for blood
transfusion a higher cut off can be used
• Pregnancy (amenorrhea) of > 24 weeks
• Patient in very bad general condition
• Patient unable to remain still or not cooperative

Ideally, there should be rapid access to blood transfusion in case of bleeding.

Materials needed:
- Gloves
- Sharps container
- 23G needle (blue)
- 5ml syringe
- Clean microscope glass slide
- Gauze swab
- Cotton wool swab
- Disinfectant (alcohol or iodine)
- Diamond pencil
- Methanol
- Registration book
- Pen
- Slide box (if transport to the lab is needed)

Procedure:
The two important prerequisites for the safety of the procedure are rapidity, so that the
needle remains within the spleen for less than 1 second; and precision, so that the entry
and exit axes of the aspirating needle are identical to avoid tearing the splenic capsule.

- Inform the patient about the procedure and get consent.

- Ask the patient to lie on his/her back.
- For young restless children, it is preferable to have two assistants; one to hold the hands
across the chest with shirt raised and the other to hold the child’s pelvis firmly.
- Palpate the extent of spleen under left costal margin.
- Clean the area of skin over the spleen with cotton wool soaked with poviodine or 70%
alcohol.
- Allow the skin to dry.
- Wipe the glass slide with dry gauze
- Clearly label the slide:

46
 o Lab Number of patient
o Test of cure, relapse or diagnosis
o Aspirate source (LN or SP)
o Date
- Take a sterile needle (23G, blue) and a 5 ml syringe.
- Attach the needle to the syringe and insert the needle under the skin.
- Create a vacuum in the syringe.
- Ask the patient to hold his/her breath
- Insert, quickly and gently, the needle into the spleen (the syringe will suck the tissue
from the spleen because there is pressure in the syringe). This process should take less
than 10 seconds. Handling of the syringe during aspiration should be done with a single
hand and axis of needle entry and exit must be the same
- Discharge the tissue onto a slide and make a smear immediately, to avoid clotting of the
aspirate
- Place the needle in the sharp container marked “SHARPS”
- Pulse and blood pressure need to be monitored every half hour for 4 hours and then
every hour for 6 hours. Patients should ideally have a few hours of bed rest. If not
possible, instruct patients to strictly avoid any vigorous physical activity in order to
minimize risk of trauma/bleeding.

47
Annex 2: Drug dosages
a. Sodium Stibogluconate (SSG) 20 mg/kg/d
• SSG comes in 30ml vials with 100 mg/ml and is given IM.
• The content of a vial should not be used more than 1 month after removing
the first dose.
• Store in a cool place (do not freeze) and protect from sunlight.
• In small children (<15 kg), the dosage is calculated in mg/m2 body surface area.

SSG dosages for children above 12 months and adults

Weight in kg Dose in ml Weight in kg Dose in ml Weight in kg Dose in ml

28 5.6 52 10.4 (5.2x2)*
5 2.0 29 5.8 53 10.6 (5.3x2)*
6 2.5 30 6.0 54 10.8 (5.4x2)*
7 2.5 31 6.2 55 11.0 (5.5x2)*
8 3.0 32 6.4 56 11.2 (5.6x2)*
9 3.0 33 6.6 57 11.4 (5.7x2)*
10 3.0 34 6.8 58 11.6 (5.8x2)*
11 3.0 35 7.0 59 11.8 (5.9x2)*
12 3.0 36 7.2 60 12.0 (6.0x2)*
13 3.0 37 7.4 61 12.2 (6.1x2)*
14 3.0 38 7.6 62 12.4 (6.2x2)*
15 3.0 39 7.8 63 12.6 (6.3x2)*
16 3.2 40 8.0 (4.0x2)* 64 12.8 (6.4x2)*
17 3.4 41 8.2 (4.1x2)* 65 13.0 (6.5x2)*
18 3.6 42 8.4 (4.2x2)* 66 13.2 (6.6x2)*
19 3.8 43 8.6 (4.3x2)* 67 13.4 (6.7x2)*
20 4.0 44 8.8 (4.4x2)* 68 13.6 (6.8x2)*
21 4.2 45 9.0 (4.5x2)* 69 13.8 (6.9x2)*
22 4.4 46 9.2 (4.6x2)* 70 14.0 (7.0x2)*
23 4.6 47 9.4 (4.7x2)* 71 14.2 (7.1x2)*
24 4.8 48 9.6 (4.8x2)* 72 14.4 (7.2x2)*
25 5.0 49 9.8 (4.9x2)* 73 14.6 (7.3x2)*
26 5.2 50 10.0 (5.0x2)* 74 14.8 (7.4x2)*
27 5.4 51 10.2 (5.1x2)* 75 15.0 (7.5x2)*

*For doses of 10 ml or more, split the dose in two syringes and inject in two different sites.

Recommended treatment for children up to 12 months of age is AmBisome.

However, in case of failure or in sites where AmBisome is not available, infants can
be treated with PM/SSG. To adjust for possible toxicity in very young children,
dosages need to be corrected for age.

48
SSG dosages for infants

Infants Infants Children

<6 months 6–12 months >12 months
Weight in kg Dose in ml Dose in ml Dose in ml
<3 0.5 0.75
contact
3 0.75 1.0
MedCo
4 1.0 1.5
5 1.0 1.5 2.0
6 1.0 2.0 2.5
7 1.0 2.0 2.5
8 1.5 2.5 3.0
9 1.5 2.5 3.0
10 1.5 2.5 3.0

b. Paromomycin sulphate 15 mg/kg/d

(equivalent to Paromomycin base 11mg/kg/d)
• Paromomycin comes in 2ml ampoules (containing 500 mg/ml Paromomycin sulphate,
equivalent to 375 mg/ml Paromomycin base) and is given IM.
• Never give Paromomycin and SSG in the same injection site.

Weight in kg Dose in ml Weight in kg Dose in ml

1-2.9 - 39-41.9 1.2
3-5.9 0.1 42-44.9 1.3
6-8.9 0.2 45-48.9 1.4
9-11.9 0.3 49-51.9 1.5
12-14.9 0.4 52-54.9 1.6
15-18.9 0.5 55-58.9 1.7
19-21.9 0.6 59-61.9 1.8
22-24.9 0.7 62-64.9 1.9
25-28.9 0.8 65-68.9 2.0
29-31.9 0.9 69-71.9 2.1
32-34.9 1.0 72-74.9 2.2
35-38.9 1.1 75 and above 2.3

49
c. AmBisome 5 mg/kg/dose
• Ambisome comes in vials of 50 mg dry powder and is given IV.
• It needs cold chain during transportation, and cool storage (<25oC).

Dose Dose
in number of vials in number of vials
Weight in kg every second day for full course Weight in kg every second day for full course
below 5 contact MedCo 35.5 - 37.9 4-4-4-4-3-3
5 – 10.4 1-1-1-1-1-1 38 – 40.4 4-4-4-4-4-3
10.5 – 12.9 2-1-1-1-1-1 40.5 – 42.9 5-4-4-4-4-4
13 – 15.4 2-2-1-1-1-1 43 – 45.4 5-5-4-4-4-4
15.5 – 17.9 2-2-2-2-1-1 45.5 – 47.9 5-5-5-5-4-4
18 – 20.4 2-2-2-2-2-1 48 – 50.4 5-5-5-5-5-4
20.5 – 22.9 2-2-2-2-2-2 50.5 – 52.9 6-5-5-5-5-5
23 – 25.4 3-2-2-2-2-2 53 – 55.4 6-6-5-5-5-5
25.5 – 27.9 3-3-3-3-2-2 55.5 – 57.9 6-6-6-6-5-5
28 – 30.4 3-3-3-3-3-2 58 – 62.9 6-6-6-6-6-6
30.5 – 32.9 4-3-3-3-3-3 63 – 67.9 7-7-7-6-6-6
33 – 35.4 4-4-3-3-3-3 68 – 72.9 7-7-7-7-7-7

How to give AmBisome

Always use complete AmBisome vials. AmBisome must be stored in a fridge. It can withstand
a short time outside the fridge; it must not be frozen.
• As AmBisome is given IV, an IV access (IV canula) is necessary.
• Dilute each vial of AmBisome with 12 ml of Water for injection; concentration of this
solution is AmBisome 4 mg/ml.
• Shake well for at least 30 seconds to completely disperse AmBisome. Visually inspect
the vial for particles and residual matter, and continue shaking until complete
dispersion is obtained.
• Prepare a 500 ml drip of Dextrose 5% [G5] (Do not use Normal Saline!).
• Let some Dextrose run out of the drip according to the numbers of vials you give:
For 1 vial of AmBisome leave 100 ml in the drip, for 2 vials leave 200 ml,
for 3 or more vials use all of the 500 ml.
• Attach the AmBisome filter to the drip of Dextrose 5% using a 21G needle.
• Add the reconstituted AmBisome to the drip by passing it through the filter.
A new filter should be used for each vial of AmBisome added.
• Mix well.
• Connect the infusion to the IV canula; allow it to run over 3 hours.
Calculate drop rate per minute according to the type of IV giving set used.
• AmBisome is given every second day until 6 doses are completed.

c. Miltefosine 2.5 mg/kg/d

50
 • Miltefosine comes in 10 mg or 50 mg capsules.
• In children (<25 kg), the dosage is calculated in mg/m2 body surface area.Contact
the KA adviser in Amsterdam for correct dosing

Weight in kg Dose in mg
<8 contact MedCo
8 -11 40
12 – 14 50
15 – 17 60
18 – 21 70
22 - 25 80
> 25 100

d. Amoxicillin 50 mg/kg/d
• Amoxicillin comes in tablets of 250 mg.

Child Child Child Child Adult

Age
below 2 months 2 m – 11 m 1 – 4 yrs 5-14 yrs 15 years and above
Weight below 4 kg 4 – 7.9 kg 8 – 14.9 kg 15 – 35 kg over 35 kg
Amount ¼x2x7 ½x2x7 1x2x7 2x2x7 3x2x7

e. Vitamin A (Retinol) single dose

• Retinol comes in 200,000 IU gel capsules. (NB: Sometimes also 50,000 IU capsules
are found.)
Age < 6 months 6 m – 1 yr > 1 year
Amount 1 drop 3 drops 1 cap

f. Artesunate/Amodiaquine (AS/AQ)
• Artesunate/Amodiaquine comes as tablets in blister packs for a full 3 day
treatment of uncomplicated Malaria, according to the weight of the patient.
Artesunate + Amodiaquine Baby (2–11 months): 25 mg AS + 67.5 mg AQ (3 tab)
Artesunate + Amodiaquine Toddler (1-5 years): 50 mg AS + 135 mg AQ (3 tab)
Artesunate + Amodiaquine Child (6-13 years): 100 mg AS + 270 mg AQ (3 tab)
Artesunate + Amodiaquine Adult (14 yrs + above): 100 mg AS + 270 mg AQ (6 tab)

Baby Toddler Child Adult

Age
below 1 yr 1– 5 yrs 6 – 13 yrs 14 yrs and above
Weight 4 – 8 kg 9 – 17 kg 18 – 35 kg over 35 kg
Day 1 1 tab Baby 1 tab Toddler 1 tab Child 2x1 tab Adult
Day 2 1 tab Baby 1 tab Toddler 1 tab Child 2x1 tab Adult
Day 3 1 tab Baby 1 tab Toddler 1 tab Child 2x1 tab Adult

g. Ceftriaxone
• Ceftriaxone comes in 250 mg and 1 g powder vials and is given IM.

51
Children and adolescents below 16 years: 50 mg/kg/d IM in 3 or 4 injections for 3-5days,
followed by a full course of Amoxicillin for 7 days.
Adults of 16 years and above: 1 g IM in 3 or 4 injections for 3 days,
followed by a full course of Amoxicillin for 7 days.

h. Ciprofloxacin 30 mg/kg/d
• Ciprofloxacin comes in 500 mg tablets, to be taken twice daily for 3 days.
Weight Amount
below 8 kg DO NOT GIVE
8 – 11.9 kg ¼x2x3
12 – 19.9 kg ½x2x3
20 kg and above 1x2x3

NB: Try to avoid Ciprofloxacin in children below the age of 15!

i. Cloxacillin 50 mg/kg/d
• Cloxacillin comes in 250 mg capsules.

Weight 8-14.9 kg 15-34.9 kg 35 kg and above

Amount 1x2x7 2x2x7 4x2x7

j. Metronidazole
• Metronidazole comes in 250 mg tablets.

Child Child Child Adult

Age
< 1 yr 1 – 4 yrs 5 – 14 yrs 15 yrs and above
Weight 4 – 7.9 kg 8 – 14.9 kg 15 – 34.9 kg 35 kg and above
Amount ½x2x7 1x2x7 2 x2x7 3x2x7

k. Metoclopramide PO and IM
• Oral Metoclopramide comes in 10 mg tablets, to be taken as long as necessary.
Weight 11 – 14.9 kg 15 - 34.9 kg 35 kg and above
Amount ¼x3 ½x3 1x3

• Injectable Metoclopramide comes in 2ml ampoules with 5 mg/ml, to be given

IM as long as necessary.
Weight 11 – 14.9 kg 15-19.9 kg 20-34.9 kg 35 kg and above
Amount 0.2 ml x 3 0.4 ml x 3 1 ml x 3 2 ml x 3

l. ORS (Oral Rehydration Salts)

Weight Sachets per day

52
 • ORS comes as 9 -11.9 kg 1 powder in sachets for
preparation 12 - 24.9 kg 1-2 with 1 l of water.
25 kg and above 2-4
m. Paracetamol (Acetaminophen) 60 mg/kg/d
• Paracetamol comes in tablets of 100 or 500 mg.
Child Child Child Child Adult
Age
<2 months 2 – 11 m 1 – 4 yrs 5 – 14 yrs 15 yrs and above
Weight up to 3.9 kg 4 – 7.9 kg 8 – 14.9 kg 15 – 35 kg over 35 kg
Amount of
½x3x3 1x3x3 2x3x3 - -
100 mg tabs
Amount of
- - ½x3x3 1x3x3 2x3x3
500 mg tabs

n. Tinidazole 50 mg/kg/d
• Tinidazole comes in 500 mg tablets.
Weight below 8 kg 8 – 13.9 kg 14 – 23.9 kg 24 – 35 kg over 35 kg
use
Amount 1x1x3 2x1x3 3x1x3 4x1x3
Metronidazole

53
 Annex 3: Treatment algorithms
Primary
Kala Azar

Severity Severe KA /
score pregnancy /
<5 jaundice

PICT pre- PICT pre-

treatment treatment

HIV test HIV HIV

HIV positive
refused negative negative

LNA:
baseline
parasite load

AmBisome
PM17/ + ART if AmBisome
5mg/kg/dosex6
+Miltefosine 5 mg/kg/dose
SSG17 possible x6
x28d

TOC pos:
TOC d 21 TOC d 21
TOC contact
only only
on d 28 KA
if still sick if still sick
Advisor

TOC neg TOC pos TOC neg TOC pos TOC pos
no
significant
significant
parasite
parasite
reduction
reduction

AmBisome
SSG18-60
PM17/ 5mg/kg/dose x6
discharge + discharge +Miltefosine
SSG17-30
weekly TOC x28d

TOC pos TOC neg TOC pos TOC neg TOC pos

PM17/
discharge
SSG17-30

TOC neg

contact
TOC pos
KA Advisor

54
 First
relapse
KA

PICT pre-
treatment

HIV test HIV

HIV positive
refused negative

severity score
<5
LNA:
no pregnancy baseline
no jaundice parasite load

AmBisome
5 mg/kg/dose
PM17/ x6 + ART
SSG30-60 +Miltefosine
x28d

weekly TOC TOC

starting d 23 on d 28+35

2x TOC pos TOC pos TOC pos

2x TOC neg
TOC neg d 60 d 35 d 35

no/ significant
no significant
parasite parasite
contact reduction
MedCo reduction

AmBisome
AmBisome PM17/ 5mg/kg/dose
5mg/kg/dose SSG30-60 x6
discharge 2x per week discharge + +Miltefosine
+ weekly TOC x28d
weekly TOC starting d 23 TOC
on d 28+35

2x TOC pos 2x TOC pos

TOC pos
TOC neg d 60 TOC neg d 35

discharge

TOC pos PM17/

d 60 SSG30-60
contact
KA Advisor
2x TOC
discharge neg

55
 2nd + 3rd
relapse
KA

HIV HIV
negative positive

LNA:
baseline
parasite load + ART

contact KA
Advisor

+ start + consider
presumptive TB co-
TB infection:
treatment choice of investigate
combination therapy
depending on
previous treatment
experiences

TOC etc
depending on
treatment

56