Cutaneous Leishmaniasis | Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis
Cutaneous Leishmaniasis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Patients older than 14 and younger than 65 years old - Skin lesions with clinical suggestion of cutaneous leishmaniasis and positive leishmanin skin test(Montenegro test)or parasitological (direct observation of leishmania amastigotes, leishmania in vitro culture from aspirates, histopathological) and molecular(Polymerase Chain Reaction - PCR)samples. - No use of oral potentially antileishmanial drugs, or topics throughout the term of the current injury. - Absence of disseminated leishmaniasis. - Absence of mucosal involvement. - Agreement to participate in the study and signed the informed consent. Exclusion Criteria: - Diabetes mellitus, kidney diseases, liver or cardiac diseases, tuberculosis, malaria. - Pregnancy - lactating mothers - Breast feeding - Cutaneous lesion with bacterial infection for which antibiotics need to be prescribed - More than six cutaneous lesions - Previous history of cutaneous or mucosal leishmaniasis - Use of drugs with potential pharmacological interactions with antimonials as anti-arrhythmic or tricycle anti-depressives - Previous intolerance to azithromycin or other macrolides or N-methylglucamine - Abusive alcohol ingestion according to the CAGE questionnaire
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Glucantime®15mg Sb+5/Kg/day, during 20 days. Maximum dose:15ml/day
Drug:Zithromax ®Zithromax ®/ Pfizer, 500 mg - 1x day, during 20 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
A - N- methyl glucamineGlucantime® , max day of 1,215 mg
B - AzithromycinZithromax ® , one dose 500 mg
Start Date: June 2008
Completed Date: September 2012
Phase: Phase 2/Phase 3
Primary Outcome: Proportion of clinically cured patients
Secondary Outcome: Proportion of patients with failure and cured
Study sponsors, principal investigator, and references
Principal Investigator: Ana Rabello, MD PhD
Lead Sponsor: Ana Rabello
Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico