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

Post-kala-azar Dermal Leishmaniasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311607
• Other study ID #: MSF PKDL STUDY
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2017
• Last updated: October 11, 2017
• Start date: April 8, 2014
• Est. completion date: October 14, 2015

Study information

• Verified date: October 2017
• Source: Medecins Sans Frontieres, Netherlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 14, 2015
• Est. primary completion date: October 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Post-kala-azar Dermal Leishmaniasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medecins Sans Frontieres, Netherlands

Outcome

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