Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis
Information source: Oswaldo Cruz Foundation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cutaneous Leishmaniasis
Intervention: Glucantime® (Drug); Zithromax ® (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Ana Rabello 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
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.
Clinical Details
Official title: Open Label Randomized Study to Assess Safety and Efficacy of Azithromycin Versus Meglumine Antimoniate to Treat Cutaneous Leishmaniasis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of clinically cured patients
Secondary outcome: Proportion of patients with failure and curedOccurrence of mucosal lesions after treatment Proportion of patients presenting new lesions Proportion of adverse events on each treatment group
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
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)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
Locations and Contacts
Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras, Presidente Tancredo Neves, Bahia 45416-000, Brazil
University Estadual de Montes Claros, Montes Claros, MG 39401-002, Brazil
Centro de Pesquisas René Rachou - Fiocruz, Belo Horizonte, Minas Gerais 30190-002, Brazil
Additional Information
Starting date: June 2008
Last updated: October 16, 2014
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