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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Oswaldo Cruz Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00682656
First received: May 20, 2008
Last updated: July 21, 2011
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, 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 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: N-metil glucamine
Drug: Azithromycin
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 ]

Secondary Outcome Measures:
  • Proportion of patients with failure [ Time Frame: twelve months after treatment ] [ Designated as safety issue: No ]
  • Occurrence of mucosal lesions after treatment [ Time Frame: twelve months after treatment ] [ Designated as safety issue: No ]
  • Proportion of patients presenting new lesions [ Time Frame: 1st 2nd 3rd 6th 12th month after treatment ] [ Designated as safety issue: No ]
  • Proportion of adverse events on each treatment group [ Time Frame: 1st 2nd 3rd 6th 12th month after treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 620
Study Start Date: June 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
N-metil glucamine
Drug: N-metil glucamine
N-metil glucamine (Glucantime®-Aventis) 15mg Sb+5/Kg/day, during 20 days. Maximum dose: 15ml/day
Experimental: B
Azithromycin
Drug: Azithromycin
Azithromycin (Zitromax®/ Pfizer) 500 mg per os 1x day, during 20 days

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 patientes. The ANVISA aproved 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
  • 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
  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

Contacts
Contact: Ana Rabello, MD, PhD 55-31-3349-7708 ana@cpqrr.fiocruz.br
Contact: Thais Amaral 55-31-3349-7712 amaralthais@cpqrr.fiocruz.br

Locations
Brazil
Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras Not yet recruiting
Presidente Tancredo Neves, Bahia, Brazil, 45416-000
Contact: Gustavo AS Romero, MD PhD    556132732811    gromero@unb.br   
Principal Investigator: Gustavo AS Romero, MD PhD         
University Estadual de Montes Claros Not yet recruiting
Montes Claros, MG, Brazil, 39401-002
Contact: Silvio FG de Carvalho, MD PhD    553888199337    guimaraescarvalho@yahoo.com.br   
Principal Investigator: Silvio FG de Carvalho, MD PhD         
Centro de Pesquisas René Rachou - Fiocruz Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30190-002
Contact: Álvaro Romanha       romanha@cpqrr.fiocruz.br   
Principal Investigator: Ana Rabello, MD, PhD         
Sub-Investigator: Thaís Amaral         
Sub-Investigator: Andrea Coutinho Faria, MD         
Sub-Investigator: Maria Camilo Senna, MD         
Sponsors and Collaborators
Oswaldo Cruz Foundation
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, Fundação Oswaldo Cruz
ClinicalTrials.gov Identifier: NCT00682656     History of Changes
Other Study ID Numbers: CEPSH/CPqRR 21/2006
Study First Received: May 20, 2008
Last Updated: July 21, 2011
Health Authority: Brazil: National Health Surveillance Agency

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

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

ClinicalTrials.gov processed this record on July 20, 2014