NCT04799236

Treatment of Mucosal Bolivian Leishmaniasis

Treatment of Bolivian Mucosal Leishmaniasis With Miltefosine, Pentavalent Antimony or Liposomal Amphotericin B

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fundacion Nacional de Dermatologia · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucosal Leishmaniasis

Interventions

Type	Name	Description
DRUG	Group 1: Miltefosine	Miltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days
DRUG	Group 2: Pentavalent Antimony	will be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes
DRUG	Group 3: Liposomal amphotericin B	3 amps (150 mg) will be administered by IV infusion iver 2 hours every other day for a total of 15 doses.

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-04-30
• Completion: 2024-11-30
• First posted: 2021-03-16
• Last updated: 2024-03-05

Locations

1 site across 1 country: Bolivia