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Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

NCT01032187 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2017-09-05

No results posted yet for this study

Summary

The purpose of this study is to determine if amphotericin B is effective against visceral leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate which is the current approved drug used for this disease in Brazil.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Meglumine antimoniate

20mg/kg/day IV for 20 days

DRUG

Amphotericin B-deoxycholate

Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • University of Brasilia

    lead OTHER

Principal Investigators

  • Myrlena RM Borges, MsC · Federal University of Tocantins

  • Gustavo AS Romero, PhD · University of Brasilia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-01-31
Completion
2010-07-31

Countries

  • Brazil

Study Locations

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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 NCT01032187 on ClinicalTrials.gov