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Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients

NCT00818818 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2010-10-08

No results posted yet for this study

Summary

This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.

Conditions

  • Localized Cutaneous Leishmaniasis

Interventions

DRUG

Meglumine antimoniate

5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days

Sponsors & Collaborators

  • University of Brasilia

    lead OTHER

Principal Investigators

  • Julia S Ampuero-Vela, MD, MSc · Faculty of Medicine, University of Brasilia

  • Gustavo Adolfo S Romero, MD, PhD · Faculty of Medicine, University of Brasilia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-01-31
Completion
2010-04-30

Countries

  • Brazil

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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 NCT00818818 on ClinicalTrials.gov