Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial

Detalhes bibliográficos
Autor(a) principal: Ramalho, Dario Brock
Data de Publicação: 2018
Outros Autores: Silva, Rosiana Estéfane da, Senna, Maria Camilo Ribeiro de, Moreira, Hugo Silva Assis, Pedras, Mariana Junqueira, Avelar, Daniel Moreira de, Saraiva, Lara, Rabello, Ana Lucia Teles, Cota, Gláucia Fernandes
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/33745
Resumo: Fundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte, MG, Brasil.
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spelling Ramalho, Dario BrockSilva, Rosiana Estéfane daSenna, Maria Camilo Ribeiro deMoreira, Hugo Silva AssisPedras, Mariana JunqueiraAvelar, Daniel Moreira deSaraiva, LaraRabello, Ana Lucia TelesCota, Gláucia Fernandes2019-07-01T13:13:56Z2019-07-01T13:13:56Z2018RAMALHO, Dario Brock et al. Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 113, n. 9, p. 1-8, 2018.0074-0276https://www.arca.fiocruz.br/handle/icict/3374510.1590/0074-02760180200engFundação Oswaldo CruzInfiltração intralesionalAntimoniato de megluminaLeishmaniose cutâneaTerapiaIntralesional infiltrationMeglumine antimoniateCutaneous leishmaniasisTherapyMeglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte, MG, Brasil.BACKGROUND: Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES: The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS: It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS: A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83082https://www.arca.fiocruz.br/bitstream/icict/33745/1/license.txt9193a7c197bc67acd023525e72a03240MD51ORIGINALMeglumine antimoniate intralesional .pdfMeglumine antimoniate intralesional .pdfapplication/pdf7105635https://www.arca.fiocruz.br/bitstream/icict/33745/2/Meglumine%20antimoniate%20intralesional%20.pdf52176217c690d2e39394b1e5ab2c0a57MD52TEXTMeglumine antimoniate intralesional .pdf.txtMeglumine antimoniate intralesional .pdf.txtExtracted texttext/plain104https://www.arca.fiocruz.br/bitstream/icict/33745/3/Meglumine%20antimoniate%20intralesional%20.pdf.txt4bd5918ab5fa4779e698b5951024cc60MD53icict/337452019-07-03 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dc.title.pt_BR.fl_str_mv Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
title Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
spellingShingle Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
Ramalho, Dario Brock
Infiltração intralesional
Antimoniato de meglumina
Leishmaniose cutânea
Terapia
Intralesional infiltration
Meglumine antimoniate
Cutaneous leishmaniasis
Therapy
title_short Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
title_full Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
title_fullStr Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
title_full_unstemmed Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
title_sort Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
author Ramalho, Dario Brock
author_facet Ramalho, Dario Brock
Silva, Rosiana Estéfane da
Senna, Maria Camilo Ribeiro de
Moreira, Hugo Silva Assis
Pedras, Mariana Junqueira
Avelar, Daniel Moreira de
Saraiva, Lara
Rabello, Ana Lucia Teles
Cota, Gláucia Fernandes
author_role author
author2 Silva, Rosiana Estéfane da
Senna, Maria Camilo Ribeiro de
Moreira, Hugo Silva Assis
Pedras, Mariana Junqueira
Avelar, Daniel Moreira de
Saraiva, Lara
Rabello, Ana Lucia Teles
Cota, Gláucia Fernandes
author2_role author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Ramalho, Dario Brock
Silva, Rosiana Estéfane da
Senna, Maria Camilo Ribeiro de
Moreira, Hugo Silva Assis
Pedras, Mariana Junqueira
Avelar, Daniel Moreira de
Saraiva, Lara
Rabello, Ana Lucia Teles
Cota, Gláucia Fernandes
dc.subject.other.pt_BR.fl_str_mv Infiltração intralesional
Antimoniato de meglumina
Leishmaniose cutânea
Terapia
topic Infiltração intralesional
Antimoniato de meglumina
Leishmaniose cutânea
Terapia
Intralesional infiltration
Meglumine antimoniate
Cutaneous leishmaniasis
Therapy
dc.subject.en.pt_BR.fl_str_mv Intralesional infiltration
Meglumine antimoniate
Cutaneous leishmaniasis
Therapy
description Fundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte, MG, Brasil.
publishDate 2018
dc.date.issued.fl_str_mv 2018
dc.date.accessioned.fl_str_mv 2019-07-01T13:13:56Z
dc.date.available.fl_str_mv 2019-07-01T13:13:56Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv RAMALHO, Dario Brock et al. Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 113, n. 9, p. 1-8, 2018.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/33745
dc.identifier.issn.pt_BR.fl_str_mv 0074-0276
dc.identifier.doi.none.fl_str_mv 10.1590/0074-02760180200
identifier_str_mv RAMALHO, Dario Brock et al. Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 113, n. 9, p. 1-8, 2018.
0074-0276
10.1590/0074-02760180200
url https://www.arca.fiocruz.br/handle/icict/33745
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Fundação Oswaldo Cruz
publisher.none.fl_str_mv Fundação Oswaldo Cruz
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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instacron_str FIOCRUZ
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