Repurposing Clinically Approved Drugs for Yaws with an Insight Into the Cutaneous Ulcer Disease S… (NCT05764876) | Clinical Trial Compass
CompletedPhase 3
Repurposing Clinically Approved Drugs for Yaws with an Insight Into the Cutaneous Ulcer Disease Syndrome (Trep-AByaws)
Papua New Guinea465 participantsStarted 2023-03-14
Plain-language summary
The goal of this clinical trial is to test the non inferiority of linezolid compared with azithromycin as a treatment for yaws . The main questions it aims to answer are: can linezolid cure active yaws, and can linezolid cure latent yaws. Participants with serologically confirmed yaws will be randomized to receive linezolid (experimental) or azithromycin (control group) treatment and followed up to assess clinical resolution.
Who can participate
Age range5 Years – 18 Years
SexALL
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Inclusion criteria
✓. Participants 5-18 years identified during an active case search program at the elementary, primary and secondary schools in the Islands Region.
✓. CUD syndrome suspected due to yaws: one or more ulcerative or nodular or papilloma skin lesion of more than 1 cm in diameter.
✓. Ability to comply with the requirements of the study protocol including follow up visits.
Exclusion criteria
✕. Children younger than 5 years old.
✕. Clinical late-stage possible yaws: destructive osteitis (rhinopharyngitis gangosa, sabre shins) or gummous nodules.
✕. Known allergy to LZD or AZI antibiotics.
✕. Pregnant or breastfeeding women.
✕. Refusal at ward level or village chief (for village inclusion), or refusal of individual or guardian (for individual inclusion).
✕. Have taken any antibiotics with potential activity against TPE within the last 7 days prior to randomization (i.e., beta lactams, cephalosporines, macrolides, tetracyclines).