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

Visceral Leishmaniasis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. weighing < 25 kg: 50 mg miltefosine daily as one capsule (50 mg) in the morning, after meals for 14 days. Parameter for evaluation

• Final cure rate (initial parasite cure and clinical assessment at six month EOT)

• Initial parasitological cure rate (based on splenic aspirates or Bone marrow aspirate)

• Clinical response at end of treatment (clinical assessment)

• Adverse events

Statistical methods

• Calculation of cure rate with 95% and 90% lower confidence limit according to Clopper Pearson

• Calculation of overall incidence of adverse events ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

• NCT number: NCT00371995
• Study type: Interventional
• Source: Banaras Hindu University
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Completion date: February 2010