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

The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Leishmaniasis
• Intervention / Treatment: Drug: Meglumine antimoniate; Drug: Pentoxifylline; Drug: Miltefosine

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • DF
    • Brasília, DF, Brazil, 70.840-901
      • Hospital Universitário de Brasília

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 - Mucosal Antimoniate and Pentoxifylline; 20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.	Drug: Meglumine antimoniate; 20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.; Drug: Pentoxifylline; Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Experimental: Group 2 - Mucosal Miltefosine and Pentoxifylline; Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.	Drug: Pentoxifylline; Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.; Drug: Miltefosine; Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.; Other Names: Miltefosnine
Experimental: Group 3 - Cutaneous Antimoniate and Pentoxifylline; 20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.	Drug: Meglumine antimoniate; 20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.; Drug: Pentoxifylline; Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Experimental: Group 4 - Cutaneous Miltefosine and Pentoxifylline; Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.	Drug: Pentoxifylline; Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.; Drug: Miltefosine; Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.; Other Names: Miltefosnine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Brasilia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimated): August 21, 2015

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pentoxifylline; Leishmaniasis; Miltefosine; Mucocutaneous
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Leishmaniasis; Leishmaniasis, Cutaneous; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Anti-Infective Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Antineoplastic Agents; Protective Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Miltefosine; Pentoxifylline; Meglumine Antimoniate
• Other Study ID Numbers: 40068714.1.0000.5558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No