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 principal: | |
|---|---|
| Publication Date: | 2014 |
| Outros Autores: | , , , , |
| Formato: | Article |
| Idioma: | eng |
| Fonte: | Repositório Institucional da UnB |
| Download full: | http://repositorio.unb.br/handle/10482/29128 https://dx.doi.org/10.1590/0037-8682-0266-2014 |
Resumo: | 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. |
| _version_ | 1871442373601394688 |
|---|---|
| author | Toledo Junior, Antonio |
| author2 | Daher, André Bastos Amaral, Thaís Alves Carvalho, Sílvio Fernando Guimarães Romero, Gustavo Adolfo Sierra Rabello, Ana |
| author2_role | author author author author author |
| author_browse | Amaral, Thaís Alves Carvalho, Sílvio Fernando Guimarães Daher, André Bastos Rabello, Ana Romero, Gustavo Adolfo Sierra Toledo Junior, Antonio |
| author_facet | Toledo Junior, Antonio Daher, André Bastos Amaral, Thaís Alves Carvalho, Sílvio Fernando Guimarães Romero, Gustavo Adolfo Sierra Rabello, Ana |
| author_role | author |
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| bitstream.url.fl_str_mv | http://repositorio.unb.br/bitstream/10482/29128/2/ARTIGO_PoorResponseAzithromycin.pdf |
| collection | Repositório Institucional da UnB |
| dc.contributor.author.fl_str_mv | Toledo Junior, Antonio Daher, André Bastos Amaral, Thaís Alves Carvalho, Sílvio Fernando Guimarães Romero, Gustavo Adolfo Sierra Rabello, Ana |
| dc.date.accessioned.fl_str_mv | 2017-12-07T05:05:26Z |
| dc.date.available.fl_str_mv | 2017-12-07T05:05:26Z |
| dc.date.issued.fl_str_mv | 2014-12 |
| dc.identifier.citation.fl_str_mv | 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. |
| dc.identifier.doi.pt_BR.fl_str_mv | https://dx.doi.org/10.1590/0037-8682-0266-2014 |
| dc.identifier.uri.fl_str_mv | http://repositorio.unb.br/handle/10482/29128 |
| dc.language.iso.fl_str_mv | eng |
| dc.publisher.none.fl_str_mv | Sociedade Brasileira de Medicina Tropical - SBMT |
| dc.rights.driver.fl_str_mv | info:eu-repo/semantics/openAccess |
| dc.source.none.fl_str_mv | reponame:Repositório Institucional da UnB instname:Universidade de Brasília (UnB) instacron:UNB |
| dc.subject.keyword.pt_BR.fl_str_mv | Azitromicina Leishmaniose cutânea Leishmania braziliensis Estudo clínico randomizado controlado Leishmaniose cutânea - tratamento |
| dc.title.pt_BR.fl_str_mv | Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil |
| dc.type.driver.fl_str_mv | info:eu-repo/semantics/article |
| dc.type.status.fl_str_mv | info:eu-repo/semantics/publishedVersion |
| description | 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | UNB_7aa1c6fb4c9cf841b65be3505c4e5bcb |
| identifier_str_mv | 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. |
| instacron_str | UNB |
| institution | UNB |
| instname_str | Universidade de Brasília (UnB) |
| language | eng |
| network_acronym_str | UNB |
| network_name_str | Repositório Institucional da UnB |
| oai_identifier_str | oai:repositorio.unb.br:10482/29128 |
| publishDate | 2014 |
| publishDateSort | 2014 |
| publisher.none.fl_str_mv | Sociedade Brasileira de Medicina Tropical - SBMT |
| reponame_str | Repositório Institucional da UnB |
| repository.mail.fl_str_mv | repositorio@unb.br |
| repository.name.fl_str_mv | Repositório Institucional da UnB - Universidade de Brasília (UnB) |
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| spelling | Toledo Junior, AntonioDaher, André BastosAmaral, Thaís AlvesCarvalho, Sílvio Fernando GuimarãesRomero, Gustavo Adolfo SierraRabello, Ana2017-12-07T05:05:26Z2017-12-07T05:05:26Z2014-12TOLEDO 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.http://repositorio.unb.br/handle/10482/29128https://dx.doi.org/10.1590/0037-8682-0266-2014Sociedade Brasileira de Medicina Tropical - SBMTRevista 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.info:eu-repo/semantics/openAccessPoor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleAzitromicinaLeishmaniose cutâneaLeishmania braziliensisEstudo clínico randomizado controladoLeishmaniose cutânea - tratamentoIntroduction 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.Faculdade de Medicina (FM)engreponame:Repositório Institucional da UnBinstname:Universidade de Brasília (UnB)instacron:UNBORIGINALARTIGO_PoorResponseAzithromycin.pdfARTIGO_PoorResponseAzithromycin.pdfapplication/pdf431354http://repositorio.unb.br/bitstream/10482/29128/2/ARTIGO_PoorResponseAzithromycin.pdff83febaa00a16e3919fb6684116901a5MD52open access10482/291282025-01-15 14:43:20.911open accessoai:repositorio.unb.br:10482/29128Repositório InstitucionalPUBhttps://repositorio.unb.br/oai/requestrepositorio@unb.bropendoar:2025-01-15T17:43:20Repositório Institucional da UnB - Universidade de Brasília (UnB) |
| spellingShingle | Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil Toledo Junior, Antonio Azitromicina Leishmaniose cutânea Leishmania braziliensis Estudo clínico randomizado controlado Leishmaniose cutânea - tratamento |
| status_str | publishedVersion |
| title | Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil |
| title_full | Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil |
| title_fullStr | Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil |
| title_full_unstemmed | Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil |
| title_short | Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil |
| title_sort | Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil |
| topic | Azitromicina Leishmaniose cutânea Leishmania braziliensis Estudo clínico randomizado controlado Leishmaniose cutânea - tratamento |
| url | http://repositorio.unb.br/handle/10482/29128 https://dx.doi.org/10.1590/0037-8682-0266-2014 |