Treatment of Mucosal Bolivian Leishmaniasis

Launched by FUNDACION NACIONAL DE DERMATOLOGIA · Mar 11, 2021

Keywords

ClinConnect Summary

This clinical trial is researching how effective and safe three different treatments are for mucosal leishmaniasis, a disease caused by a parasite. The treatments being compared are miltefosine (an oral medication), LAMB (a type of intravenous treatment), and pentavalent antimony (another intravenous option). By gathering data on how well these treatments work and how they are tolerated by patients, the study aims to help doctors and patients choose the best option for managing this condition.

To participate in the trial, individuals must be over 45 kg (about 99 lbs) and have a confirmed diagnosis of mucosal leishmaniasis, which means their doctor has identified the parasite through tests. Those who have been treated for leishmaniasis in the past year, have certain health issues, or are women of childbearing age who cannot commit to using reliable birth control for four months after starting treatment are not eligible. Participants can expect to receive one of the treatments and will be closely monitored for their health and how well the treatment works. This study is currently recruiting, and it welcomes participants of all genders aged between 4382 and 23740 days old.

Gender

ALL

Eligibility criteria

• 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.