The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
Leishmaniasis
About this trial
This is an interventional treatment trial for Leishmaniasis focused on measuring Leishmaniasis, Mucocutaneous, Miltefosine, Pentoxifylline
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitário de Brasília
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Group 1 - Mucosal Antimoniate and Pentoxifylline
Group 2 - Mucosal Miltefosine and Pentoxifylline
Group 3 - Cutaneous Antimoniate and Pentoxifylline
Group 4 - Cutaneous Miltefosine and Pentoxifylline
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.
20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.