Health Condition 1: null- Post Kala Azar Dermal Leishmaniasis
Conditions
Interventions
Intervention1: Liposomal Amphotericin B (Ambisome�®)
: Ambisome�® monotherapy regimen (5 x 4 mg/kg IV, twice per week, total dose of 20 mg/kg) Total duration of 15 days (Ambisome injections at D1
Sponsors
Drugs for Neglected Diseases initiative DNDi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed PKDL case by clinical presentation and demonstration of parasites by microscopy in a skin smear or biopsy or by qPCR, with stable or progressive disease for at least 4 months 2. Male or Female patients aged 6 to 60 years 3. Written voluntarily informed consent from adult patient and from parent / guardian in case of children
Exclusion criteria
Exclusion criteria: 1. Patients who had prior treatment of PKDL within last 2 years. 2. Pregnant and lactating women and women of childbearing age (12 to 55 years) who, before randomization, cannot be assured contraceptive cover during treatment and 5 months thereafter 3. Patients with sign and symptoms of severe diseases: defined as suffering from a concomitant severe infection such as TB or any other serious known underlying disease (cardiac, renal, hepatic) 4. Severe malnutrition defined by BMI for age WHO reference curves for gender, Z score 19-years old 5. Patients with haemoglobin 6. Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range. 7. Patients with total bilirubin levels >1.5 times the upper normal range 8. Patients with serum creatinine above the upper normal range 9. Patients with serum potassium 10. Patients with a positive HIV test as applicable 11. Patients / guardian not willing to participate 12. Patients with history of allergy or hypersensitivity to the relevant study drug 13. Patients on immunomodulators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the efficacy (definitive cure at 12 months) of two treatment regimens in subjects with PKDL according to clinical criteria: complete resolution of papular and nodular lesions (flattening of 100% of lesions) and significant improvement ( 80% re-pigmentation) of macular lesions by 12 months after the end of treatment.Timepoint: Follow up patients by 12 months after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the maximal accumulation of total amphotericin B and miltefosine in the skin at the end of treatment and correlate these with plasma levels. To assess the change in immune response during and after end of treatment as compared to baseline by measuring cytokines profiles level in the peripheral blood. To assess the clearance of parasites by microscopy and qPCR at various time-points before, during and after treatment and during follow-up Timepoint: Follow up patients by 12 months after the end of treatment. | — |
Countries
Bangladesh, India
Contacts
Public ContactDr Vishal Goyal
Drugs for Neglected Diseases initiative
Outcome results
None listed