Clinical Trial: Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India

Brief Summary: Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.

Detailed Summary:

Methodology Multicenter trial, eligible patients will be treated with Liposomal amphotericin B (5 mg/kg) on day 1 and then with miltefosine capsules for 14 days (days 2-15).

At two weeks after the end of treatment the initial cure (clinical and parasitological cure) and the clinical response will be determined. If initial cure is observed, a patient will be evaluated after a 6 months (after end of treatment) follow up period for final clinical cure.

Number of patients planned Total number of patients planned: 150 patients at both centers combined. 75 pediatric (2-11 years); 75 adult (12-65 years).

Lack of suitability for the trial:

  • Post Kala-azar Dermal Leishmaniasis (PKDL)
  • Concomitant treatment with other anti-leishmanial drugs
  • Any condition which compromises ability to comply with the study procedures

Administrative reasons:

  • Any condition or situation that compromises compliance with study procedures including follow-up visit Study medication, dose and mode of administration Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.

Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)

Dosage:

  1. weighing ≥ 25 kg: 100 mg miltefosine daily as one capsule (50 mg) in the morning and one capsule in the evening, after meals for 14 days.
  2. Sponsor: Banaras Hindu University

    Current Primary Outcome: Final Cure six months after the end of treatment [ Time Frame: 1 year ]

    Original Primary Outcome: Final Cure six months after the end of treatment

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Banaras Hindu University

    Dates:
    Date Received: September 5, 2006
    Date Started: October 2007
    Date Completion:
    Last Updated: June 21, 2011
    Last Verified: September 2008