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NCT Number: NCT03311607

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

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Key information

Conditions

Post-kala-azar Dermal Leishmaniasis Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Visceral Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AmBisome

Drug

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

Primary outcomes

  1. Final outcome

    Time frame: 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 outcomes

  1. Safety

    Time frame: 7 weeks

    Adverse events and serious adverse events were recorded during and up to one month after treatment.

  2. Hypokalaemia

    Time frame: 7 weeks

    Assessment of hypokalaemia was based on serum potassium, measured in blood samples taken at different times during and after treatment.

Sponsors and collaborators

Lead sponsor

Medecins Sans Frontieres, Netherlands

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 17, 2017
Registry last updated
Oct 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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