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Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis

NCT00317980 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2009-01-22

No results posted yet for this study

Summary

The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

Meglumine antimoniate

Meglumine antimoniate 5mg/kg/d for 20 days

DRUG

Meglumine antimoniate

Meglumine antimoniate 15 mg/kg/d for 20 days

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • University of Brasilia

    lead OTHER

Principal Investigators

  • Gustavo S Romero, MD · University of Brasilia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-03-31
Completion
2008-12-31

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 NCT00317980 on ClinicalTrials.gov