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

Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02530697
• Other study ID #: 40068714.1.0000.5558
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: August 2026

Study information

• Verified date: January 2024
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• Meglumine antimoniate
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.
• Miltefosine
Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.
• Pentoxifylline
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.

Locations

Country	Name	City	State
Brazil	Hospital Universitário de Brasília	Brasília	DF

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

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