Actively Recruiting
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Led by University of Brasilia · Updated on 2023-09-15
100
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
CONDITIONS
Official Title
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active confirmed cutaneous leishmaniasis or mucosal leishmaniasis
- Use of highly effective contraceptive method and a negative pregnancy test if female in fertile phase
- Agree and sign informed consent form
You will not qualify if you...
- Previous treatment with leishmanicidal drugs in the last 6 months
- Electrocardiographic changes contraindicating liposomal amphotericin B (QTc > 450ms)
- Serum creatinine or urea 1.5 times above normal limit
- Severe or decompensated liver, kidney, heart disease, or diabetes mellitus
- History of hypersensitivity to liposomal amphotericin B, miltefosine, or pentoxifylline
- Pregnant or breastfeeding women
- Patients with AIDS or other immunodeficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario de Brasilia
Brasília, Federal District, Brazil, 70840-901
Actively Recruiting
Research Team
R
Raimunda Sampaio, PhD
CONTACT
S
Sofia Martins, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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