Back to resultsSafety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh
Primary Purpose
Post-kala-azar Dermal Leishmaniasis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
AmBisome
Sponsored by
About this trial
This is an interventional treatment trial for Post-kala-azar Dermal Leishmaniasis focused on measuring Post-kala-azar Dermal Leishmaniasis, Visceral Leishmaniasis, AmBisome, Liposomal amphotericin B, Bangladesh, Kala azar
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cohort treated with AmBisome 15 mg/kg
Arm Description
280 patients, receiving AmBisome
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety
Adverse events and serious adverse events were recorded during and up to one month after treatment.
Hypokalaemia
Assessment of hypokalaemia was based on serum potassium, measured in blood samples taken at different times during and after treatment.
Full Information
NCT ID
NCT03311607
First Posted
October 3, 2017
Last Updated
October 11, 2017
Sponsor
Medecins Sans Frontieres, Netherlands
1. Study Identification
Unique Protocol Identification Number
NCT03311607
Brief Title
Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 8, 2014 (Actual)
Primary Completion Date
October 14, 2015 (Actual)
Study Completion Date
October 14, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medecins Sans Frontieres, Netherlands
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-kala-azar Dermal Leishmaniasis
Keywords
Post-kala-azar Dermal Leishmaniasis, Visceral Leishmaniasis, AmBisome, Liposomal amphotericin B, Bangladesh, Kala azar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort treated with AmBisome 15 mg/kg
Arm Type
Other
Arm Description
280 patients, receiving AmBisome
Intervention Type
Drug
Intervention Name(s)
AmBisome
Intervention Description
A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule
Primary Outcome Measure Information:
Title
Final outcome
Description
The final outcome at 12 months was scored after carefully visual evaluation of the progress of all lesions of each patient compared to baseline.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety
Description
Adverse events and serious adverse events were recorded during and up to one month after treatment.
Time Frame
7 weeks
Title
Hypokalaemia
Description
Assessment of hypokalaemia was based on serum potassium, measured in blood samples taken at different times during and after treatment.
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koert Ritmeijer, PhD
Organizational Affiliation
Medecins Sans Frontieres, Netherlands
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh
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