Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

Condition(s) targeted: Cutaneous Leishmaniasis

Intervention: N-metil glucamine (Drug); Azithromycin (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Oswaldo Cruz Foundation

Official(s) and/or principal investigator(s):
Ana Rabello, MD PhD, Principal Investigator, Affiliation: Oswaldo Cruz Foundation
Isabela Ribeiro, MD, Study Director, Affiliation: Drugs for Neglected Diseases

Overall contact:
Ana Rabello, MD, PhD, Phone: 55-31-3349-7708, Email: ana@cpqrr.fiocruz.br

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, pentavalents 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 in the southeast Brazil and in Corte de Pedras (Bahia), Northeastern Brazil. The patients follow up lasts for 12 months.

Official title: Open Label Randomized Study to Assess Safety and Efficacy of Azithromycin Versus Meglumine Antimoniate to Treat Cutaneous Leishmaniasis

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Proportion of clinically cured patients

Secondary outcome:

Proportion of patients with failure

Occurrence of mucosal lesions after treatment

Proportion of patients presenting new lesions

Proportion of adverse events on each treatment group

Minimum age: 14 Years. Maximum age: 65 Years. Gender(s): Both.

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)

- Agreement to participate in the study and signed the informed consent

Exclusion Criteria:

- Diabetes mellitus, kidney diseases, liver or cardiac diseases, tuberculosis, malaria.

- Pregnancy

- 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-metilglucamine

- Abusive alcohol ingestion according to the CAGE questionnaire

Ana Rabello, MD, PhD, Phone: 55-31-3349-7708, Email: ana@cpqrr.fiocruz.br

Centro de Pesquisas René Rachou - Fiocruz, Belo Horizonte, Minas Gerais 30190-002, Brazil; Recruiting
Álvaro Romanha, Email: romanha@cpqrr.fiocruz.br
Ana Rabello, MD, PhD, Principal Investigator
Marcela Orsini, MD, PhD, Sub-Investigator
Antonio Toledo, MD, MSc, Sub-Investigator
Mariana Pedras, BSc, MSc, Sub-Investigator

Starting date: June 2008
Ending date: June 2010
Last updated: June 16, 2009