Oral treatment for leishmaniasis in elderly patients
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
This study is testing if a new oral treatment for leishmaniasis works better and is safer than the standard intravenous treatment for older patients.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Brasilia Academic / other |
| Locations | 1 site (Brasília, Federal District) |
| Trial ID | NCT06040489 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of oral miltefosine combined with pentoxifylline compared to intravenous liposomal amphotericin B for treating cutaneous and mucosal leishmaniasis in elderly patients. The study aims to determine the safety and efficacy of these treatments in a randomized clinical trial format. Participants will be monitored for treatment outcomes and any adverse effects associated with the medications used.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly individuals with active confirmed cases of cutaneous or mucosal leishmaniasis.
Not a fit: Patients who have received leishmanicidal drugs in the past six months or have severe underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer oral treatment option for elderly patients suffering from leishmaniasis.
How similar studies have performed: While there have been studies on leishmaniasis treatments, this specific combination approach in elderly patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Brasília, Federal District
- Hospital Universitario de Brasilia — Brasília, Federal District, Brazil (Recruiting)
Study contacts
- Study coordinator: Raimunda Sampaio, PhD
- Email: rnrsampaio@hotmail.com
- Phone: +556120285415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.