Treatment of Mucosal Bolivian Leishmaniasis

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Nacional de Dermatologia
• Collaborators: ABF Foundation for Medical Research; Centro Nacional de Enfermedades Tropicales CENETROP; Hospital Dermatologico de Jorochito
• Treatments: Amphotericin B; Liposomal amphotericin B; Miltefosine

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.