Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

NCT00682656 | Terminated Phase 2

• 1 other identifier: CEPSH/CPqRR 21/2006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Cutaneous Leishmaniasis

Keywords

cutaneous leishmaniasis; azithromycin; N- methyl glucamine

Outcome Measures

Primary Outcomes (1)

• Proportion of clinically cured patients

  A cure was defined as complete lesion healing and re-epithelialization without inflammatory infiltration and erythema until 90 days after the treatment ended.

  at the third month after treatment

Secondary Outcomes (4)

• Proportion of patients with failure and cured

  twelve months after treatment

• Occurrence of mucosal lesions after treatment

  twelve months after treatment

• Proportion of patients presenting new lesions

  1st 2nd 3rd 6th 12th month after treatment

• Proportion of adverse events on each treatment group

  1st 2nd 3rd 6th 12th month after treatment.

Study Arms (2)

A - N- methyl glucamine

ACTIVE COMPARATOR

Glucantime® , max day of 1,215 mg

Drug: Glucantime®

B - Azithromycin

EXPERIMENTAL

Zithromax ® , one dose 500 mg

Drug: Zithromax ®

Interventions

Glucantime® DRUG

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

Also known as: meglumine antimoniate

A - N- methyl glucamine

Zithromax ® DRUG

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

Also known as: SELIMAX®

B - Azithromycin

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ana Rabello: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (3)

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

Presidente Tancredo Neves, Estado de Bahia, 45416-000, Brazil

Location

Centro de Pesquisas René Rachou - Fiocruz

Belo Horizonte, Minas Gerais, 30190-002, Brazil

Location

University Estadual de Montes Claros

Montes Claros, Minas Gerais, 39401-002, Brazil

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Meglumine Antimoniate; Azithromycin

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Ana Rabello, MD PhD

  Oswaldo Cruz Foundation

  PRINCIPAL INVESTIGATOR

• Isabela Ribeiro, MD

  Drugs for Neglected Diseases

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Ana Rabello

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: October 17, 2014

Record last verified: 2011-07

Locations

BR (3)