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Treatment of Mucosal Bolivian Leishmaniasis

NCT04799236 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-03-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospital Dermatologico de Jorochito

    collaborator UNKNOWN

  • Centro Nacional de Enfermedades Tropicales CENETROP

    collaborator UNKNOWN

  • ABF Foundation for Medical Research

    collaborator UNKNOWN

  • Fundacion Nacional de Dermatologia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2024-04-30
Completion
2024-11-30

Countries

  • Bolivia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04799236 on ClinicalTrials.gov