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Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

NCT00682656 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-10-17

No results posted yet for this study

Summary

The adequate treatment of the American tegumentary leishmaniasis is crucial since the disease, differently from the caused by the Old World species, is painful and not self-healing and may lead to the disfiguring mucosal involvement. So far, pentavalent antimony compounds have been considered the treatment of choice for cutaneous leishmaniasis (CL), however, these drugs present high frequency of side effects and important disadvantages as parenteral administration and need for careful renal and cardiac monitoring. Azithromycin is a macrolide antibiotic, non-expensive, largely commercially available that has shown in-vitro and in vivo activity against different species of Leishmania.

The main objective of this study is to evaluate the efficacy and safety of oral azithromycin for the treatment of CL. The efficacy of oral treatment of azithromycin 500 mg/day for 20 days is going to be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (Glucantime®) for 20 days in patients with CL from two endemic regions of Brazil: the metropolitan region of Belo Horizonte and Montes Claros (MG)in the southeast Brazil and in Corte de Pedras (Bahia), Northeastern Brazil. The patients follow up lasts for 12 months.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

Glucantime®

15mg Sb+5/Kg/day, during 20 days. Maximum dose:15ml/day

DRUG

Zithromax ®

Zithromax ®/ Pfizer, 500 mg - 1x day, during 20 days

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Ana Rabello

    lead OTHER

Principal Investigators

  • Ana Rabello, MD PhD · Oswaldo Cruz Foundation

  • Isabela Ribeiro, MD · Drugs for Neglected Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-12-31
Completion
2012-09-30

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 NCT00682656 on ClinicalTrials.gov