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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized clinical trial to compare two treatments for cutaneous and mucosal forms of American Tegumentary Leishmaniasis in people aged 50 and older. The study aims to evaluate oral miltefosine combined with pentoxifylline versus intravenous liposomal amphotericin B. This pilot study is sponsored by the University of Brasilia and includes phases 2 and 3 to assess treatment outcomes in the elderly population. Participants receive either oral miltefosine 50mg twice daily combined with oral pentoxifylline 400mg three times daily, or intravenous liposomal amphotericin B dosed between 25 to 40 mg/kg. The treatments target both cutaneous and mucosal leishmaniasis, with separate groups for each condition receiving the respective therapies. The study is randomized without masking to compare these treatment approaches. During the trial, participants are monitored for cure rates at 90 days after starting treatment. Safety is assessed by recording adverse effects up to 30 days after stopping the drugs. Participants must give informed consent and undergo blood tests and electrocardiograms to confirm eligibility. The study involves regular clinical evaluations to track treatment response and side effects, with total involvement lasting at least three months post-treatment.
CONDITIONS
Brief 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 a 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 greater than 450ms)
- Serum creatinine or urea 1.5 times above normal
- 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 Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 90 days
Participants receive oral Miltefosine and Pentoxifylline or intravenous Liposomal Amphotericin B depending on their assigned group to treat cutaneous or mucosal leishmaniasis.
Duration - 30 days after drug interruption
Participants are monitored for adverse effects and treatment outcomes after drug completion.
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
S
Sofia Martins, PhD
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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