Efficacy and safety of Miltefosin in comparison with Liposomal Anfotericin B for the treatment of Leishmaniasis

Centro de Pesquisa Rene Rachou, Fundação Oswaldo Cruz0 个研究点开始时间: 2018年1月15日最近更新: 2023年5月29日

试验速览

暂无简介。

•Both sexes; age greater than 18 years; mucosal impairment; parasitological confirmation of Leishmania infection by one or more of the following methods: parasitological examination (direct examination or culture), histopathology, immunohistochemistry or molecular test; consentiment form signed; availability for the schedule of the study

•Women in reproductive age with positive (serum) pregnancy test at the time of screening; or lactating women; or women who can not or will not use contraception during and for up to 3 months after discontinuation of treatment; Carriers of HIV infection or other immunodebilitating condition; hepatic enzimes levels 3 times above the upper limit of normal, according to reference values; previous treatment for LM in the 6 months prior to study inclusion; previous treatment with leishmanicidal drugs indicated for the treatment of other diseases in the last six months prior to inclusion;use of medications that interfere with the therapeutic response or that cause interactions with drug of the study; A history of hypersensitivity to the drugs being tested; renal, cardiac, hepatic or psychiatric disease that at the discretion of the investigator represents a contraindication to the use of some of the treatment alternatives included in this study; disseminated leishmaniasis concomitant with mucosal involvement; intravenous drug users or other chemical dependencies; Sjogren-Larson syndrome

发起方

Centro de Pesquisa Rene Rachou, Fundação Oswaldo Cruz