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

NCT ID: NCT00317980

Last Updated: 2009-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-12-31

Brief 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.

Detailed Description

The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the pentavalent antimonial meglumine antimoniate. The treatment with meglumine antimoniate is toxic and at least some of the more relevant adverse events associated with that drug are dose-dependent. Recently, some research developed in Brazil has shown evidence that lower doses of pentavalent antimony are equally efficacious as compared to the standard-dose regimen. That evidence has been obtained in patients from the State of Rio de Janeiro who were infected by Leishmania (Viannia) braziliensis. The purpose of the study is to evaluate the safety and efficacy of the low-dose pentavalent antimony regimen in patients with cutaneous leishmaniasis infected by Leishmania (Viannia) braziliensis living in a rural area of the State of Bahia, Brazil, where cutaneous leishmaniasis is highly endemic. The usefulness of the study is based on the possibility to reduce the toxicity observed during treatment and the treatment costs.

The main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes:

• Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 5 mg/kg/d intravenous for 20 days
• Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 15 mg/kg/d intravenous for 20 days

The clinical outcomes of cure or failure will be evaluated until the third month of follow-up.

Conditions

Cutaneous Leishmaniasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low dose

Meglumine antimoniate 5 mg/kg/d for 20 days

Group Type: EXPERIMENTAL

Meglumine antimoniate

Intervention Type: DRUG

Meglumine antimoniate 5mg/kg/d for 20 days

Standard dose

Meglumine antimoniate 15 mg/kg/d for 20 days

Group Type: ACTIVE_COMPARATOR

Meglumine antimoniate

Intervention Type: DRUG

Meglumine antimoniate 15 mg/kg/d for 20 days

Interventions

Meglumine antimoniate

Meglumine antimoniate 5mg/kg/d for 20 days

Intervention Type: DRUG

Meglumine antimoniate

Meglumine antimoniate 15 mg/kg/d for 20 days

Intervention Type: DRUG

Other Intervention Names

Glucantime; Glucantime

Eligibility Criteria

Inclusion Criteria

• Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis
• Disease duration of 2 to 20 weeks
• Positive leishmanin skin test
• Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp

Exclusion Criteria

• History of past episode of leishmaniasis
• Mucosal disease
• Disseminated disease
• Use of drugs with anti-leishmanial activity
• Contraindications for using pentavalent antimony:

• pregnancy
• renal failure
• heart failure
• hepatic failure
• Other diseases:

• active tuberculosis
• hanseniasis

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

University of Brasilia

OTHER

Sponsor Role: lead

Responsible Party

Nucleo de Medicina Tropical, University of Brasilia

Principal Investigators

Gustavo S Romero, MD

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Locations

Núcleo de Medicina Tropical, University of Brasilia

Brasília, Federal District, Brazil

Countries

Brazil

References

Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. Treatment of American cutaneous leishmaniasis: a comparison between low dosage (5 mg/kg/day) and high dosage (20 mg/kg/day) antimony regimens. Pathol Biol (Paris). 1997 Jun;45(6):496-9.

Reference Type: BACKGROUND

PMID: 9309267 (View on PubMed)

Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. A low-dose antimony treatment in 159 patients with American cutaneous leishmaniasis: extensive follow-up studies (up to 10 years). Am J Trop Med Hyg. 1997 Dec;57(6):651-5. doi: 10.4269/ajtmh.1997.57.651.

Reference Type: BACKGROUND

PMID: 9430521 (View on PubMed)

Other Identifiers

NMT-LD-CP-2006

Identifier Type: -

Identifier Source: org_study_id