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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 cured

Occurrence 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

Page last updated: August 23, 2015

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