Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis (PCL01)
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.
Drug: Zithromax ®
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Randomized Study to Assess Safety and Efficacy of Azithromycin Versus Meglumine Antimoniate to Treat Cutaneous Leishmaniasis|
- Proportion of clinically cured patients [ Time Frame: at the third month after treatment ] [ Designated as safety issue: No ]A cure was defined as complete lesion healing and re-epithelialization without inflammatory infiltration and erythema until 90 days after the treatment ended.
- Proportion of patients with failure and cured [ Time Frame: twelve months after treatment ] [ Designated as safety issue: No ]Proportion of cured patients at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment. Mean time to healing.
- Occurrence of mucosal lesions after treatment [ Time Frame: twelve months after treatment ] [ Designated as safety issue: No ]Proportion of patients with relapsed or mucosal lesion in 6 months, 9 and 12 follow-up after completion of treatment.
- Proportion of patients presenting new lesions [ Time Frame: 1st 2nd 3rd 6th 12th month after treatment ] [ Designated as safety issue: No ]Proportion of patients with new lesions at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment.
- Proportion of adverse events on each treatment group [ Time Frame: 1st 2nd 3rd 6th 12th month after treatment. ] [ Designated as safety issue: Yes ]Proportion of patients clinical, electrocardiographic and laboratory adverse events.
|Study Start Date:||June 2008|
|Study Completion Date:||September 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: A - N- methyl glucamine
Glucantime® , max day of 1,215 mg
15mg Sb+5/Kg/day, during 20 days. Maximum dose:15ml/day
Other Name: meglumine antimoniate
Experimental: B - Azithromycin
Zithromax ® , one dose 500 mg
Drug: Zithromax ®
Zithromax ®/ Pfizer, 500 mg - 1x day, during 20 days
Other Name: SELIMAX®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682656
|Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras|
|Presidente Tancredo Neves, Bahia, Brazil, 45416-000|
|University Estadual de Montes Claros|
|Montes Claros, MG, Brazil, 39401-002|
|Centro de Pesquisas René Rachou - Fiocruz|
|Belo Horizonte, Minas Gerais, Brazil, 30190-002|
|Principal Investigator:||Ana Rabello, MD PhD||Oswaldo Cruz Foundation|
|Study Director:||Isabela Ribeiro, MD||Drugs for Neglected Diseases|