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

Phase 4

Completed

• Conditions: Post-kala-azar Dermal Leishmaniasis
• Interventions: Drug: AmBisome

• Registration Number: NCT03311607
• Lead Sponsor: Medecins Sans Frontieres, Netherlands

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 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

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.

Study Timeline

• Study Start: 2014-04-08
• Primary Completion: 2015-10-14
• Study Completion: 2015-10-14
• Status Verified: 2017-10
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-11
• Last Update Submitted: 2017-10-11
• Study First Posted: 2017-10-17
• Last Update Posted: 2017-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort treated with AmBisome 15 mg/kg	AmBisome	280 patients, receiving AmBisome

Primary Outcome Measures

Name	Time	Method
Final outcome	12 months	The final outcome at 12 months was scored after carefully visual evaluation of the progress of all lesions of each patient compared to baseline.

Secondary Outcome Measures

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