UnknownPhase 3

Treatment of Mucosal Bolivian Leishmaniasis

Bolivia120 participantsStarted 2021-04-01

Plain-language summary

The purpose of this protocol is to conduct a randomized comparison of the efficacy and tolerance of miltefosine, LAMB, and pentavalent antimony for the treatment of mucosal leishmaniasis. With such controlled pharmacodynamic data, and additional considerations of administrative convenience (oral \>\>IV) and cost, we hope that it will be possible for policy makers, treatment professionals, and patients to choose the most appropriate therapy for ML.

Who can participate

Age range12 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * weight over 45 kg * Parasitological confirmation of the lesion will be made by visualization of Leishmania, culture of Leishmania, or molecular identification of Leishmania (PCR) from the biopsy or aspirate of the lesion. Exclusion Criteria: * Previous treatment for leishmaniasis in the last 12 months * concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment * values of complete blood count, liver function (aspartate aminotransferase, alkaline phosphatase), renal function (creatinine), pancreatic function (lipase), or uric acid beyond 1.5 x normal range * EKG with clinically significant abnormalities * Women of childbearing age not agreeing with the use of secure reproductive contraception for 4 months after initiating miltefosine therapy.

What they're measuring

Healing of mucosal lesions

Timeframe: Baseline to 12 month follow up

Trial details

NCT IDNCT04799236

SponsorFundacion Nacional de Dermatologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30

Contact for this trial

jaime soto, MD

+59175648894 jasm.dlb@gmail.com

View on ClinicalTrials.gov More Mucosal Leishmaniasis trials