Status:
COMPLETED
Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh
Lead Sponsor:
Medecins Sans Frontieres, Netherlands
Conditions:
Post-kala-azar Dermal Leishmaniasis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief 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 olde...
Detailed Description
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 old...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2015
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03311607
Start Date
April 8 2014
End Date
October 14 2015
Last Update
October 17 2017
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