Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) i… (NCT06040489) | Clinical Trial Compass
RecruitingPhase 2/3
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Brazil100 participantsStarted 2022-06-22
Plain-language summary
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
Who can participate
Age range50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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