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

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.

Study Overview

• Status: Completed
• Conditions: Post-kala-azar Dermal Leishmaniasis
• Intervention / Treatment: Drug: AmBisome

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 Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medecins Sans Frontieres, Netherlands

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2014
• Primary Completion (ACTUAL): October 14, 2015
• Study Completion (ACTUAL): October 14, 2015

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (ACTUAL): October 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Bangladesh; AmBisome; Liposomal amphotericin B; Post-kala-azar Dermal Leishmaniasis; Visceral Leishmaniasis; Kala azar
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Leishmaniasis; Leishmaniasis, Visceral; Anti-Infective Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Liposomal amphotericin B
• Other Study ID Numbers: MSF PKDL STUDY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes