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

Phase 2

Active, not recruiting

• Conditions: Leishmaniasis
• Interventions: Drug: Miltefosine; Drug: Meglumine antimoniate; Drug: Pentoxifylline

• Registration Number: NCT02530697
• Lead Sponsor: University of Brasilia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
• For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
• Ages between 18 and 80 years old;
• Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
• Agree to participate in the study and sign the informed consent term.

Exclusion Criteria

• Use of any leishmanicidal drugs six months prior;
• Clinical or laboratorial evidences of electrocardiographic disorders;
• Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
• Hypersensitivity to meglucamine antimoniate;
• Pregnancy or lactation;
• Fertile females that do not agree to use contraceptive methods;
• Patients that do not agree to the informed consent term.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - Mucosal Miltefosine and Pentoxifylline	Pentoxifylline	Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.
Group 1 - Mucosal Antimoniate and Pentoxifylline	Pentoxifylline	20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.
Group 2 - Mucosal Miltefosine and Pentoxifylline	Miltefosine	Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.
Group 3 - Cutaneous Antimoniate and Pentoxifylline	Pentoxifylline	20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.
Group 4 - Cutaneous Miltefosine and Pentoxifylline	Miltefosine	Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.
Group 4 - Cutaneous Miltefosine and Pentoxifylline	Pentoxifylline	Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.
Group 1 - Mucosal Antimoniate and Pentoxifylline	Meglumine antimoniate	20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.
Group 3 - Cutaneous Antimoniate and Pentoxifylline	Meglumine antimoniate	20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.

Primary Outcome Measures

Name	Time	Method
Cure	90 days	Complete healing of previous lesions until the 90th day after the begin of the treatment
Failure	90 days	Lesions fail to heal until the 90th day after the begin of the treatment
Relapse	90 days	Lesions that reappear on the scar of a previously healed lesion

Trial Locations

Locations (1)

Hospital Universitário de Brasília; 🇧🇷 Brasília, DF, Brazil