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

Cutaneous Leishmaniasis Clinical Trial

— Lowdosesb  

Official title:

Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317980
• Other study ID #: NMT-LD-CP-2006
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2006
• Last updated: January 20, 2009
• Start date: February 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• Meglumine antimoniate
Meglumine antimoniate 5mg/kg/d for 20 days
• Meglumine antimoniate
Meglumine antimoniate 15 mg/kg/d for 20 days

Locations

Country	Name	City	State
Brazil	Núcleo de Medicina Tropical, University of Brasilia	Brasilia	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
University of Brasilia	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

Oliveira-Neto MP, Schubach A, Mattos M, Gonçalves-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of clinically cured patients at the third month after treatment		Three months after treatment	No
Primary	Proportion of patients with epithelialized lesions		Three months after treatment	No
Secondary	Proportion of patients with adherence to the protocol prescribed drug		30 days	No
Secondary	Proportion of patients with adverse events		30 days after treatment	Yes
Secondary	Proportion of patients with late failure after the first three months of follow-up		12 months	No