Título:	Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil
Autor(es):	Toledo Junior, Antonio Daher, André Bastos Amaral, Thaís Alves Carvalho, Sílvio Fernando Guimarães Romero, Gustavo Adolfo Sierra Rabello, Ana
Assunto:	Azitromicina Leishmaniose cutânea Leishmania braziliensis Estudo clínico randomizado controlado Leishmaniose cutânea - tratamento
Data de publicação:	Dez-2014
Editora:	Sociedade Brasileira de Medicina Tropical - SBMT
Referência:	TOLEDO JUNIOR, Antonio et al. Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil. Revista da Sociedade Brasileira de Medicina Tropical, Uberaba, v. 47, n. 6, p. 756-762, nov./dez. 2014. DOI: https://doi.org/10.1590/0037-8682-0266-2014. Disponível em: https://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822014000600756&lng=en&tlng=en. Acesso em: 22 jul. 2020.
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.
Unidade Acadêmica:	Faculdade de Medicina (FMD)
Licença:	Revista 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.
DOI:	https://dx.doi.org/10.1590/0037-8682-0266-2014
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