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