Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil

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Autor(es): dc.creatorToledo Junior, Antonio-
Autor(es): dc.creatorDaher, André Bastos-
Autor(es): dc.creatorAmaral, Thaís Alves-
Autor(es): dc.creatorCarvalho, Sílvio Fernando Guimarães-
Autor(es): dc.creatorRomero, Gustavo Adolfo Sierra-
Autor(es): dc.creatorRabello, Ana-
Data de aceite: dc.date.accessioned2021-10-14T18:24:51Z-
Data de disponibilização: dc.date.available2021-10-14T18:24:51Z-
Data de envio: dc.date.issued2017-12-07-
Data de envio: dc.date.issued2017-12-07-
Data de envio: dc.date.issued2014-12-
Fonte completa do material: dc.identifierhttp://repositorio.unb.br/handle/10482/29128-
Fonte completa do material: dc.identifierhttps://dx.doi.org/10.1590/0037-8682-0266-2014-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/capes/631061-
Descrição: dc.descriptionIntroduction 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.-
Formato: dc.formatapplication/pdf-
Idioma: dc.languageen-
Publicador: dc.publisherSociedade Brasileira de Medicina Tropical - SBMT-
Direitos: dc.rightsAcesso Aberto-
Direitos: dc.rightsRevista da Sociedade Brasileira de Medicina Tropical - (CC BY-NC) - This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Fonte: https://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822014000600756&lng=en&tln g=en. Acesso em: 22 jul. 2020.-
Palavras-chave: dc.subjectAzitromicina-
Palavras-chave: dc.subjectLeishmaniose cutânea-
Palavras-chave: dc.subjectLeishmania braziliensis-
Palavras-chave: dc.subjectEstudo clínico randomizado controlado-
Palavras-chave: dc.subjectLeishmaniose cutânea - tratamento-
Título: dc.titlePoor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil-
Tipo de arquivo: dc.typelivro digital-
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