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

Medecins Sans Frontieres, Netherlands

Status and phase

Completed

Phase 4

Conditions

Post-kala-azar Dermal Leishmaniasis

Treatments

Drug: AmBisome

Study type

Interventional

Funder types

Other

Identifiers

NCT03311607

MSF PKDL STUDY

Details and patient eligibility

About

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.

Full 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.

Enrollment

280 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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