Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis
Status:
Terminated
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Ana Rabello
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico