Multicenter study evaluating the efficacy and safety of Intralesional administration of Meglumine Antimoniate compared to Systemic treatment for Cutaneous Leishmaniasis

Instituto Nacional de Infectologia Evandro Chagas (INI) -Fiocruz0 个研究点开始时间: 2018年3月8日最近更新: 2023年5月29日

试验速览

暂无简介。

•Inclusion criteria
•Patients who are able to sign the informed consent and willing to participate in the study as subjects attending the follow-up visits as foreseen by the study schedule;
•Patients who present up to a maximum of three lesions with or without ulceration;
•Patients with confirmed parasitic infection by Leishmania by scraping or imprint or histopathological examination or culture or immunohistochemistry or by polymerase chain reaction;
•Patients who present lesions with a maximum of 5 cm in diameter for a single lesion or up to 3 cm for two lesions or up to 2 cm in the case of three lesions;

•Women of childbearing age who do not use contraceptive methods or do so improperly;
•Pregnant Women;
•Children under the age of 13;
•Patients with lesions in the cephalic segment;
•Patients who have had previous treatment with MA;
•Patients with disseminated or diffuse or recidiva cutis leishmaniasis;
•Patients with of any form of leishmaniasis with mucous membrane involvement;
•Patients with concomitant use of any medication with recognized toxic interactions with Sb5+ which cannot be substituted over the study period;
•Patients with comorbid conditions such as heart or kidney or liver diseases.

发起方

Instituto Nacional de Infectologia Evandro Chagas (INI) -Fiocruz