Clinical trial NCT00682656: Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis
Official title: Open Label Randomized Study to Assess Safety and Efficacy of Azithromycin Versus Meglumine Antimoniate to Treat Cutaneous Leishmaniasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Cutaneous Leishmaniasis
Keywords: cutaneous leishmaniasis
azithromycin
N- methyl glucamine
Lead sponsor: Oswaldo Cruz Foundation
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2008-05-22
Enrollment: 48
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of clinically cured patients
timeFrame: at the third month after treatment
Secondary outcomes:
measure: Proportion of patients with failure and cured
timeFrame: twelve months after treatment
measure: Occurrence of mucosal lesions after treatment
timeFrame: twelve months after treatment
measure: Proportion of patients presenting new lesions
timeFrame: 1st 2nd 3rd 6th 12th month after treatment
measure: Proportion of adverse events on each treatment group
timeFrame: 1st 2nd 3rd 6th 12th month after treatment.
Other outcomes:
Locations:
city: Presidente Tancredo Neves
country: Brazil
facility: Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras
state: Bahia
city: Montes Claros
country: Brazil
facility: University Estadual de Montes Claros
state: MG
city: Belo Horizonte
country: Brazil
facility: Centro de Pesquisas René Rachou - Fiocruz
state: Minas Gerais
Study officials:
affiliation: Oswaldo Cruz Foundation
name: Ana Rabello, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drugs for Neglected Diseases
name: Isabela Ribeiro, MD
role: STUDY_DIRECTOR
References: