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

June 21, 2011 updated by: Banaras Hindu University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Bihar
      • Muzaffarpur, Bihar, India, 842001
        • Kala-azar Medical Research Center
      • Patna, Bihar, India
        • Rajendra Memorial Research Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female age between 2 and 65 years (inclusive)
  • Parasites visualized on splenic aspiration
  • Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia)
  • Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate
  • Fever for at least 2 weeks
  • Written informed consent from the patient/or from parent or guardian if under 18 years old

Exclusion Criteria:

  • Hemoglobin < 6 g/dl
  • White blood cell count < 1000/mm3
  • Platelets <50,000
  • Prothrombin time > 5 sec above control
  • ASAT > 3 times the upper limit of normal
  • Serum creatinine or BUN > 1.5 times the upper limit of normal
  • Malaria
  • Tuberculosis
  • HIV positive serology
  • Lactation, pregnancy
  • Refusing contraception method during treatment period plus 3 months
  • Any medical condition(s) that upon judgment of physician may affect the safety of the patient when treated with study drugs
  • Any concomitant drug that is nephrotoxic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1

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)
Drug: Liposomal amphotericin B and Miltefosine

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)

Other Names:
  • AmBisome and Impavido

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Final Cure six months after the end of treatment
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banaras Hindu University

Collaborators

Rajendra Memorial Research Institute of Medical Sciences

Investigators

  • Principal Investigator: Shyam Sundar, MD, Banaras Hindu University
  • Principal Investigator: Prabhat K Sinha, MD, Rajendra Memorial Research Institute of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria

September 5, 2006

First Posted (Estimate)

September 6, 2006

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEI PDE 06 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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