Phase 3 Study Comparing Safety and Effectiveness of Contezolid AcefosamilContezolid Versus Linezolid for Treating Moderate to Severe Diabetic Foot Infections in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of contezolid acefosamil given intravenously and contezolid given orally compared to linezolid given both intravenously and orally in adults with moderate or severe diabetic foot infections DFI. This Phase 3, multicenter, randomized, and double-blind study involves about 865 adult participants diagnosed with DFI caused or suspected to be caused by Gram-positive bacteria. The study aims to compare how well these treatments resolve infection signs and symptoms without the need for further therapy. Participants will be randomly assigned to receive either contezolid acefosamilcontezolid or linezolid for a total of 14 to 28 days, with dosing ranging from 28 to 56 doses depending on the treatment length. The study maintains blinding so that neither participants nor researchers know which treatment is given. Treatments are administered via intravenous and oral routes, and the study follows up on participants through various assessments after treatment completion. During the trial, participants will undergo evaluations including clinical response assessments for infection resolution, monitoring of adverse events, blood tests such as complete blood counts, and vital signs checks like heart rate. These evaluations occur around 28 to 35 days after finishing therapy. The primary outcome focuses on the percentage of participants whose infection signs and symptoms resolve without needing additional treatment by Day 35. Safety and secondary clinical responses are also closely monitored throughout the study period, which lasts up to June 2026.

Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)