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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-5r93wn

Enrollment

Unknown

Registered

2018-01-15

Start date

2018-03-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous mucosal Leishmaniasis

Interventions

Miltefosine group: 46 patients will receive Miltefosine, 2.5 mg / kg / day orally, with a maximum of 150 mg / day, 2 or 3 times daily for 28 days. Amphotericin B liposomal daily infusion: 46 patients

Drug

D02.540.576.500.500

Eligibility

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
cure rate with the treatments evaluated by the absolute number and percentage of cured patients compared to treated patients. Cure is defined by absence of inflamation at 180 days	—

Secondary

Measure	Time frame
Secondary outcome 1: late cure rate of the treatments evaluated by the absolute number and percentage of cured patients compared to treated patients. Cure is defined by absence of inflamation at 360 days ;Secondary outcome 2: adverse events rate with the treatment evaluated by the number of patients with adverse events compared to all treated patients; a clinical and laboratory record previously set will be used	—

Measure

Time frame

Secondary outcome 1: late cure rate of the treatments evaluated by the absolute number and percentage of cured patients compared to treated patients. Cure is defined by absence of inflamation at 360 days ;Secondary outcome 2: adverse events rate with the treatment evaluated by the number of patients with adverse events compared to all treated patients; a clinical and laboratory record previously set will be used

—

Countries

Brazil

Contacts

Public ContactGláucia Cota

Centro de Pesquisa Rene Rachou, Fundação Oswaldo Cruz

cota@minas.fiocruz.br553133497712

Outcome results

None listed

Source: REBEC (via WHO ICTRP)