Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis

Inclusion Criteria:

• Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis
• Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase
• Agree and sing informed consent form

Exclusion Criteria:

• Previous treatment with leishmanicidal drugs in the last 6 months
• Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms)
• Serum creatinine or urea 1.5 times the upper limit of normal
• Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus
• history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline
• Pregnant and breastfeeding women
• Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency