Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh

Study Overview
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Brief Summary
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The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.

Detailed Description
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The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, was evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This was a prospective study, with the objective to assess final cure 12 months after treatment. Clinical response was monitored at 1, 3, 6, and 12 months after treatment, and safety during and up until one month after treatment. A total of 280 patients recruited between 8 April and 25 November 2014 received AmBisome. Of these, 272 were assessed at 12 months.

Official Title
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Safety and Effectiveness of Short-course AmBisome in the Treatment of Post-Kala-azar Dermal Leishmaniasis (PKDL): a Prospective Cohort Study in Bangladesh

Conditions
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Post-kala-azar Dermal Leishmaniasis

Intervention / Treatment
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* Drug: AmBisome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Patients of 12 years and older with probable PKDL (skin lesions strongly suggestive of PKDL with exclusion of other skin diseases, a history of VL treatment and a positive serological rK39 test) Exclusion Criteria: PKDL and concurrent VL Prior treatment for PKDL On medication with a side effect profile overlapping with that of AmBisome A known hypersensitivity to AmBisome Pregnant and lactating women, Known cardiac disease, hepatic impairment or another severe chronic underlying disease -Renal impairment (baseline serum creatinine > 1.3 mg/dL) Serum potassium <3.5mmol/L at baseline

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort treated with AmBisome 15 mg/kg<br>280 patients, receiving AmBisome | Drug: AmBisome<br>* A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final outcome | The final outcome at 12 months was scored after carefully visual evaluation of the progress of all lesions of each patient compared to baseline. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse events and serious adverse events were recorded during and up to one month after treatment. | 7 weeks | 
| Hypokalaemia | Assessment of hypokalaemia was based on serum potassium, measured in blood samples taken at different times during and after treatment. | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AmBisome, Liposomal amphotericin B, Bangladesh, Kala azar, Post-kala-azar Dermal Leishmaniasis, Visceral Leishmaniasis