Status:
TERMINATED
Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis
Lead Sponsor:
Ana Rabello
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00682656
Start Date
June 1 2008
End Date
September 1 2012
Last Update
October 17 2014
Active Locations (3)
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1
Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras
Presidente Tancredo Neves, Estado de Bahia, Brazil, 45416-000
2
Centro de Pesquisas René Rachou - Fiocruz
Belo Horizonte, Minas Gerais, Brazil, 30190-002
3
University Estadual de Montes Claros
Montes Claros, Minas Gerais, Brazil, 39401-002