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The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil

NCT02530697 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-01-16

No results posted yet for this study

Summary

Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.

Conditions

  • Leishmaniasis

Interventions

DRUG

Meglumine antimoniate

20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.

DRUG

Miltefosine

Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.

DRUG

Pentoxifylline

Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.

Sponsors & Collaborators

  • University of Brasilia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2025-08-31
Completion
2026-08-31

Countries

  • Brazil

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 NCT02530697 on ClinicalTrials.gov