Treatment of Bolivian Mucosal Leishmaniasis With Miltefosine, Pentavalent Antimony or Liposomal Amphotericin B
Who is this study for? Patients with Bolivian mucosal leishmaniasis
What treatments are being studied? Amphotericin B
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Plurinational State of Bolivia
Hospital Dermatologico de Jorochito
RECRUITING
Santa Cruz De La Sierra
Contact Information
Primary
jaime soto, MD
jasm.dlb@gmail.com
+59175648894
Backup
Paula Soto, MD
dra.paula.dermalaser@gmail.com
+59175648893
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2024-11-30
Participants
Target number of participants: 120
Treatments
Active_comparator: Group 1: Oral Miltefosine
Miltefosine will be administered per os at 150 mg/day \[50 mg tid\] for 28 days. This is the standard regimen of miltefosine for persons \>45 kg.
Active_comparator: Group 2: Intravenous pentavalent antimony
IV pentavalent antimony (meglumine antimoniate) will be administrated at 20 mg x kg x d during 20 consecutive days. Antimony will be diluted in 10 times its volume in 5%Dextrose in destilled water and injected IV in 20 minutes
Experimental: Group 3: Intravenous liposomal amphotericin B
LAMB will be administered IV at 3 ampules \[150 mg\] on each of days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Three ampules is the individual dose suggested by Aronson et al \[2016\] and equals 2.5 mg/kg/dose for a 60 kg person. 15 doses of 3 ampules (total of 2250 mg) equals 37.5 mg/kg for a 60 kg person.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Dermatologico de Jorochito, ABF Foundation for Medical Research, Centro Nacional de Enfermedades Tropicales CENETROP
Leads: Fundacion Nacional de Dermatologia