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NCT Number: NCT02530697

The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A 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.

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Key information

Conditions

Leishmaniasis Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitário de Brasília

Brasília, Federal District, 70.840-901, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meglumine antimoniate

Drug

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

Miltefosine

Drug

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

Other names: Miltefosnine

Pentoxifylline

Drug

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

Primary outcomes

  1. Cure

    Time frame: 90 days

    Complete healing of previous lesions until the 90th day after the begin of the treatment

  2. Failure

    Time frame: 90 days

    Lesions fail to heal until the 90th day after the begin of the treatment

  3. Relapse

    Time frame: 90 days

    Lesions that reappear on the scar of a previously healed lesion

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Aug 21, 2015
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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