Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis (PCL01)
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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 |
- Proportion of clinically cured patients [ Time Frame: at the third month after treatment ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Ana Rabello, MD, PhD | 55-31-3349-7708 | ana@cpqrr.fiocruz.br |
| Contact: Thais Amaral | 55-31-3349-7712 | amaralthais@cpqrr.fiocruz.br |
| 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 | |
| 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 May 19, 2013