NCT06040489 Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
| NCT ID | NCT06040489 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Brasilia |
| Condition | Leishmaniasis; Brazilian |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-06-22 |
| Primary Completion | 2024-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2022-06-22 with a primary completion date of 2024-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06040489 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Leishmaniasis; Brazilian. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06040489 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06040489 currently recruiting?
Yes, NCT06040489 is actively recruiting participants. Contact the research team at rnrsampaio@hotmail.com for enrollment information.
Where is the NCT06040489 trial being conducted?
This trial is being conducted at Brasília, Brazil.
Who is sponsoring the NCT06040489 clinical trial?
NCT06040489 is sponsored by University of Brasilia. The trial plans to enroll 100 participants.