Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Leishmaniasis; Brazilian, Leishmaniasis, Mucocutaneous
About this trial
This is an interventional treatment trial for Leishmaniasis; Brazilian focused on measuring Elderly, Miltefosine, Leishmaniasis, Pentoxifylline, Liposomal amphotericin b, Treatment
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario de BrasiliaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis
Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis