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Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis (PCL01)

This study has been terminated.
(Efficacy issues on test arm)
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Ana Rabello, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00682656
First received: May 20, 2008
Last updated: October 16, 2014
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Cutaneous Leishmaniasis
Drug: Glucantime®
Drug: Zithromax ®
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Randomized Study to Assess Safety and Efficacy of Azithromycin Versus Meglumine Antimoniate to Treat Cutaneous Leishmaniasis

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • Proportion of clinically cured patients [ Time Frame: at the third month after treatment ] [ Designated as safety issue: No ]
    A cure was defined as complete lesion healing and re-epithelialization without inflammatory infiltration and erythema until 90 days after the treatment ended.


Secondary Outcome Measures:
  • Proportion of patients with failure and cured [ Time Frame: twelve months after treatment ] [ Designated as safety issue: No ]
    Proportion of cured patients at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment. Mean time to healing.

  • Occurrence of mucosal lesions after treatment [ Time Frame: twelve months after treatment ] [ Designated as safety issue: No ]
    Proportion of patients with relapsed or mucosal lesion in 6 months, 9 and 12 follow-up after completion of treatment.

  • Proportion of patients presenting new lesions [ Time Frame: 1st 2nd 3rd 6th 12th month after treatment ] [ Designated as safety issue: No ]
    Proportion of patients with new lesions at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment.

  • Proportion of adverse events on each treatment group [ Time Frame: 1st 2nd 3rd 6th 12th month after treatment. ] [ Designated as safety issue: Yes ]
    Proportion of patients clinical, electrocardiographic and laboratory adverse events.


Enrollment: 48
Study Start Date: June 2008
Study Completion Date: September 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A - N- methyl glucamine
Glucantime® , max day of 1,215 mg
Drug: Glucantime®
15mg Sb+5/Kg/day, during 20 days. Maximum dose:15ml/day
Other Name: meglumine antimoniate
Experimental: B - Azithromycin
Zithromax ® , one dose 500 mg
Drug: Zithromax ®
Zithromax ®/ Pfizer, 500 mg - 1x day, during 20 days
Other Name: SELIMAX®

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

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682656

Locations
Brazil
Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras
Presidente Tancredo Neves, Bahia, Brazil, 45416-000
University Estadual de Montes Claros
Montes Claros, MG, Brazil, 39401-002
Centro de Pesquisas René Rachou - Fiocruz
Belo Horizonte, Minas Gerais, Brazil, 30190-002
Sponsors and Collaborators
Ana Rabello
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Ana Rabello, MD PhD Oswaldo Cruz Foundation
Study Director: Isabela Ribeiro, MD Drugs for Neglected Diseases
  More Information

No publications provided

Responsible Party: Ana Rabello, Dr. Ana Rabello, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00682656     History of Changes
Other Study ID Numbers: CEPSH/CPqRR 21/2006
Study First Received: May 20, 2008
Last Updated: October 16, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Oswaldo Cruz Foundation:
cutaneous leishmaniasis
azithromycin
N- methyl glucamine

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Meglumine antimoniate
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014