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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cutaneous Leishmaniasis

Intervention / Treatment
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* Drug: Meglumine antimoniate
* Drug: Meglumine antimoniate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>Meglumine antimoniate 5 mg/kg/d for 20 days | Drug: Meglumine antimoniate<br>* Meglumine antimoniate 5mg/kg/d for 20 days<br>* Other names: Glucantime;|
| Active Comparator: Standard dose<br>Meglumine antimoniate 15 mg/kg/d for 20 days | Drug: Meglumine antimoniate<br>* Meglumine antimoniate 15 mg/kg/d for 20 days<br>* Other names: Glucantime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of clinically cured patients at the third month after treatment |  | Three months after treatment | 
| Proportion of patients with epithelialized lesions |  | Three months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with adherence to the protocol prescribed drug |  | 30 days | 
| Proportion of patients with adverse events |  | 30 days after treatment | 
| Proportion of patients with late failure after the first three months of follow-up |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous leishmaniasis, Leishmania braziliensis, Pentavalent antimony, Meglumine antimoniate