RecruitingPhase 2Phase 3NCT06040489
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Sponsor
University of Brasilia
Enrollment
100 participants
Start Date
Jun 22, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
Eligibility
Min Age: 50 Years
Inclusion Criteria3
- 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 Criteria7
- 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
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Interventions
DRUGMiltefosine 50mg
Oral Miltefosine 50mg bid
DRUGPentoxifylline 400mg
Oral Pentoxifylline 400mg tid
DRUGLiposomal Amphotericin B
Intravenous 25 to 40mg/kg
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06040489