Comparison of the effect and toxicity between two options for the treatment of Mucosal Leishmaniasis: Miltefosin and Liposomal Anfotericin B

Phase 3

• Conditions: Cutaneous mucosal Leishmaniasis; C03.752.300.500; B55.2

• Registration Number: RBR-5r93wn
• Lead Sponsor: Centro de Pesquisa Rene Rachou, Fundação Oswaldo Cruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified