NCT03311607

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Medecins Sans Frontieres, Netherlands · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-kala-azar Dermal Leishmaniasis

Interventions

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

Timeline

• Start date: 2014-04-08
• Primary completion: 2015-10-14
• Completion: 2015-10-14
• First posted: 2017-10-17
• Last updated: 2017-10-17

Regulatory

• FDA-regulated drug study