NCT03311607

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

October 3, 2017

Last Update Submit

October 11, 2017

Conditions

Post-kala-azar Dermal Leishmaniasis

Keywords

Post-kala-azar Dermal LeishmaniasisVisceral LeishmaniasisAmBisomeLiposomal amphotericin BBangladeshKala azar

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Safety

    7 weeks

  • Hypokalaemia

    7 weeks

Study Arms (1)

Cohort treated with AmBisome 15 mg/kg

OTHER

280 patients, receiving AmBisome

Drug: AmBisome

Interventions

AmBisomeDRUG

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

Cohort treated with AmBisome 15 mg/kg

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Study Officials

  • Koert Ritmeijer, PhD

    Medecins Sans Frontieres, Netherlands

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 17, 2017

Study Start

April 8, 2014

Primary Completion

October 14, 2015

Study Completion

October 14, 2015

Last Updated

October 17, 2017

Record last verified: 2017-10