Treatment of Mucosal Bolivian Leishmaniasis

Fundacion Nacional de Dermatologia

Status and phase: Enrolling; Phase 3

Conditions: Mucosal Leishmaniasis

Treatments: Drug: Group 2: Pentavalent Antimony; Drug: Group 1: Miltefosine; Drug: Group 3: Liposomal amphotericin B

Study type: Interventional

Funder types: Other

Identifiers

NCT04799236

ABF-BO-2021-100

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 3 patient groups

Group 1: Oral Miltefosine

Active Comparator group

Description:

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.

Treatment:

Drug: Group 1: Miltefosine

Group 2: Intravenous pentavalent antimony

Active Comparator group

Description:

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

Treatment:

Drug: Group 2: Pentavalent Antimony

Group 3: Intravenous liposomal amphotericin B

Experimental group

Description:

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.

Treatment:

Drug: Group 3: Liposomal amphotericin B