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Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
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; Cota, Gláucia.
  • Ramalho, Dario Brock; Fundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte. BR
  • Silva, Rosiana Estéfane da; Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte. BR
  • Senna, Maria Camilo Ribeiro de; Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte. BR
  • Moreira, Hugo Silva Assis; Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte. BR
  • Pedras, Mariana Junqueira; Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte. BR
  • Avelar, Daniel Moreira de; Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte. BR
  • Saraiva, Lara; Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte. BR
  • Rabello, Ana; Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte. BR
  • Cota, Gláucia; Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias. Belo Horizonte. BR
Mem. Inst. Oswaldo Cruz ; 113(9): e180200, 2018. tab, graf
Article in English | LILACS | ID: biblio-955123
Responsible library: BR1.1
ABSTRACT
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% CI77-96%). 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).
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Organometallic Compounds / Leishmaniasis, Cutaneous Limits: Humans Language: English Journal: Mem. Inst. Oswaldo Cruz Journal subject: Tropical Medicine / Parasitology Year: 2018 Type: Article / Project document Affiliation country: Brazil Institution/Affiliation country: Fundação Hospitalar do Estado de Minas Gerais/BR / Fundação Oswaldo Cruz/BR

Full text: Available Index: LILACS (Americas) Main subject: Organometallic Compounds / Leishmaniasis, Cutaneous Limits: Humans Language: English Journal: Mem. Inst. Oswaldo Cruz Journal subject: Tropical Medicine / Parasitology Year: 2018 Type: Article / Project document Affiliation country: Brazil Institution/Affiliation country: Fundação Hospitalar do Estado de Minas Gerais/BR / Fundação Oswaldo Cruz/BR