Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

Launched by UNIVERSITY OF BRASILIA · Sep 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for a disease called leishmaniasis, which can affect the skin and mucous membranes. Researchers are comparing an oral medication called miltefosine, combined with another drug called pentoxifylline, against a more traditional treatment delivered through an IV called liposomal amphotericin B. The trial is specifically looking at elderly patients who have active cases of either cutaneous (skin) or mucosal (affecting the mouth or nose) leishmaniasis.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of leishmaniasis. Women who can become pregnant must use effective birth control and have a negative pregnancy test. However, people with certain health issues, such as severe heart or kidney problems, or those who have recently been treated for leishmaniasis, are not eligible. Participants will receive either of the two treatments and will be monitored by the research team throughout the study. This trial aims to find out which treatment is more effective and better tolerated by older adults.

Gender

ALL

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