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

NCT ID: NCT03311607

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-08

Study Completion Date

2015-10-14

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.

Conditions

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Post-kala-azar Dermal Leishmaniasis

Keywords

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Post-kala-azar Dermal Leishmaniasis Visceral Leishmaniasis AmBisome Liposomal amphotericin B Bangladesh Kala azar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort treated with AmBisome 15 mg/kg

280 patients, receiving AmBisome

Group Type OTHER

AmBisome

Intervention Type DRUG

A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule

Interventions

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AmBisome

A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule

Intervention Type DRUG

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medecins Sans Frontieres, Netherlands

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Koert Ritmeijer, PhD

Role: STUDY_DIRECTOR

Medecins Sans Frontieres, Netherlands

Other Identifiers

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MSF PKDL STUDY

Identifier Type: -

Identifier Source: org_study_id