Status:
RECRUITING
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Lead Sponsor:
University of Brasilia
Conditions:
Leishmaniasis; Brazilian
Leishmaniasis, Mucocutaneous
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief Summary
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06040489
Start Date
June 22 2022
End Date
June 1 2026
Last Update
September 15 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario de Brasilia
Brasília, Federal District, Brazil, 70840-901