Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
NCT ID: NCT06040489
Last Updated: 2023-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2022-06-22
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
Miltefosine 50mg
Oral Miltefosine 50mg bid
Pentoxifylline 400mg
Oral Pentoxifylline 400mg tid
Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
Miltefosine 50mg
Oral Miltefosine 50mg bid
Pentoxifylline 400mg
Oral Pentoxifylline 400mg tid
Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis
Liposomal Amphotericin B
Intravenous 25 to 40mg/kg
Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis
Liposomal Amphotericin B
Intravenous 25 to 40mg/kg
Interventions
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Miltefosine 50mg
Oral Miltefosine 50mg bid
Pentoxifylline 400mg
Oral Pentoxifylline 400mg tid
Liposomal Amphotericin B
Intravenous 25 to 40mg/kg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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University of Brasilia
OTHER
Responsible Party
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Locations
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Hospital Universitario de Brasilia
Brasília, Federal District, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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57768421.0.0000.5558
Identifier Type: -
Identifier Source: org_study_id
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