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

NCT03311607 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2017-10-17

No results posted yet for this study

Summary

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.

Conditions

  • Post-kala-azar Dermal Leishmaniasis

Interventions

DRUG

AmBisome

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

Sponsors & Collaborators

  • Medecins Sans Frontieres, Netherlands

    lead OTHER

Principal Investigators

  • Koert Ritmeijer, PhD · Medecins Sans Frontieres, Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-08
Primary Completion
2015-10-14
Completion
2015-10-14
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311607 on ClinicalTrials.gov