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To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar

NCT00876824 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2011-06-02

No results posted yet for this study

Summary

The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).

Conditions

  • Leishmaniasis, Visceral

Interventions

DRUG

Amphotericin B Lipid emulsion

Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A for treatment of Visceral Leishmaniasis

DRUG

Liposomal Amphotericin B

Liposomal Amphotericin B in visceral leishmaniasis - 15 mg/kg on day 1 in group B

Sponsors & Collaborators

  • Ministry of Science and Technology

    collaborator AMBIG

  • Bharat Serums and Vaccines Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Gautam Daftary, MBBS · Bharat Serums and Vaccines Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876824 on ClinicalTrials.gov