Cutaneous Leishmaniasis Clinical Trial
Official title:
Open Label Randomized Study to Assess Safety and Efficacy of Azithromycin Versus Meglumine Antimoniate to Treat Cutaneous Leishmaniasis
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.
Included a new site (University Estadual de Montes Claros - UNIMONTES) in 7 June 2010. The site was included due the need to achieve more patients. The ANVISA (National Agency of Sanitary Surveillance) approved these site in March 2011 and the start of activities is planned for June 2011. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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