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

Sponsor

Medecins Sans Frontieres, Netherlands (Other)

Overall Status

Completed

CT.gov ID

NCT03311607

Collaborator

(none)

280

Enrollment

Arm

18.2

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-kala-azar Dermal Leishmaniasis	Drug: AmBisome	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

280 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective cohort studyProspective cohort study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 8, 2014

Actual Primary Completion Date :

Oct 14, 2015

Actual Study Completion Date :

Oct 14, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Cohort treated with AmBisome 15 mg/kg 280 patients, receiving AmBisome	Drug: AmBisome A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule

Arm

Intervention/Treatment

Other: Cohort treated with AmBisome 15 mg/kg

280 patients, receiving AmBisome

Drug: AmBisome

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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