Author | Toledo Junior, Antonio | |
Author | Daher, André Bastos | |
Author | Amaral, Thaís Alves | |
Author | Carvalho, Sílvio Fernando Guimarães | |
Author | Romero, Gustavo Adolfo Sierra | |
Author | Rabello, Ana Lúcia Teles | |
Access date | 2018-10-23T12:03:58Z | |
Available date | 2018-10-23T12:03:58Z | |
Document date | 2014 | |
Citation | TOLEDO JUNIOR, Antonio Carlos de Castro. Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil. Rev. Soc. Bras. Med. Trop., v. 47, n. 6, p. 756-762, 2014 | pt_BR |
ISSN | 0037-8682 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/29680 | |
Language | eng | pt_BR |
Publisher | Sociedade Brasileira de Medicina Tropical | pt_BR |
Rights | open access | pt_BR |
Subject in Portuguese | Azitromicina | pt_BR |
Subject in Portuguese | Leishmaniose cutânea | pt_BR |
Subject in Portuguese | Leishmania braziliensis | pt_BR |
Subject in Portuguese | Teste controlado e aleatório | pt_BR |
Subject in Portuguese | Antimoniato de meglumina | pt_BR |
Title | Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil. | pt_BR |
Type | Article | pt_BR |
DOI | 10.1590/0037-8682-0266-2014 | |
Abstract | Introduction: Parenteral antimony-based compounds are still the standard of care for cutaneous leishmaniasis (CL) treatment in many countries, despite their high toxicity. Previous studies showed that oral azithromycin could be an option for CL treatment. The aim of this study was to evaluate efficacy and safety of oral azithromycin (AZ) for CL treatment compared with injectable meglumine antimoniate (MA).
Methods: This was a randomized, open-label, 2-arm, non-inferiority clinical trial. Treatment-naïve patients with localized CL were treated with MA (15mg/kg/day up to 1,215mg) or AZ (500mg/day) during 20 consecutive days. The primary efficacy end point was a CL cure 90 days after treatment completion. The analysis was performed with intention-to-treat (ITT) and per protocol (PP) analyses. After an anticipated interim analysis, the study was interrupted due to the high failure rate in the azithromycin group.
Results: Twenty-four volunteers were included in each group. The MA group had a higher cure rate than the AZ group with the ITT and PP analyses, which were 54.2% versus 20.8% [relative risk (RR) 1.97; 95% confidence intervals (95%CI) 1.13-3.42] and 72.2% versus 23.8% (RR 3.03; 95%CI 1.34-6.87), respectively. No unexpected adverse events were observed.
Conclusions: Azithromycin is ineffective for CL treatment and does not seem to have a role in the therapeutic arsenal for CL. | pt_BR |
Affilliation | Universidade José do Rosário Vellano. Serviço Multiprofissional de Infectologia. Belo Horizonte, MG, Brasil | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Vice-Presidência de Pesquisa e Laboratórios de Referência. Plataforma de Pesquisa Clínica. Rio de Janeiro, RJ, Brasil/Fundação Oswaldo Cruz. Farmanguinhos. Departamento de Pesquisa Clínica. Rio de Janeiro, RJ, Brasil | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Vice-Presidência de Pesquisa e Laboratórios de Referência. Plataforma de Pesquisa Clínica. Rio de Janeiro, RJ, Brasil | pt_BR |
Affilliation | Universidade Estadual de Montes Claros. Hospital Universitário Clemente de Faria. Departamento de Doenças Infecciosas. Montes Claros, MG, Brasil | pt_BR |
Affilliation | Universidade de Brasília. Núcleo de Medicina Tropical. Brasília, DF, Brasil | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Laboratório de Pesquisa Clínica. Belo Horizonte, MG, Brasil | pt_BR |
Subject | Azithromycin | pt_BR |
Subject | Cutaneous leishmaniasis | pt_BR |
Subject | Leishmania braziliensis | pt_BR |
Subject | Randomized controlled trial | pt_BR |
Subject | Meglumine antimoniate | pt_BR |