Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

NCT ID: NCT00682656

Last Updated: 2014-10-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-09-30

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.

Conditions

Cutaneous Leishmaniasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A - N- methyl glucamine

Glucantime® , max day of 1,215 mg

Group Type: ACTIVE_COMPARATOR

Glucantime®

Intervention Type: DRUG

15mg Sb+5/Kg/day, during 20 days. Maximum dose:15ml/day

B - Azithromycin

Zithromax ® , one dose 500 mg

Group Type: EXPERIMENTAL

Zithromax ®

Intervention Type: DRUG

Zithromax ®/ Pfizer, 500 mg - 1x day, during 20 days

Interventions

Glucantime®

15mg Sb+5/Kg/day, during 20 days. Maximum dose:15ml/day

Intervention Type: DRUG

Zithromax ®

Zithromax ®/ Pfizer, 500 mg - 1x day, during 20 days

Intervention Type: DRUG

Other Intervention Names

meglumine antimoniate; SELIMAX®

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Ana Rabello

OTHER

Sponsor Role: lead

Responsible Party

Ana Rabello

Dr. Ana Rabello

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ana Rabello, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oswaldo Cruz Foundation

Isabela Ribeiro, MD

Role: STUDY_DIRECTOR

Drugs for Neglected Diseases

Locations

Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras

Presidente Tancredo Neves, Estado de Bahia, Brazil

Centro de Pesquisas René Rachou - Fiocruz

Belo Horizonte, Minas Gerais, Brazil

University Estadual de Montes Claros

Montes Claros, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

CEPSH/CPqRR 21/2006

Identifier Type: -

Identifier Source: org_study_id