A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults with Moderate or Severe Diabetic Foot Infections

Diabetic Foot Infections

1. The primary objective is to evaluate the Investigator’s assessment of clinical response at the D35 visit in subjects receiving contezolid acefosamil/contezolid compared to subjects receiving linezolid in the MITT analysis set, 2. Evaluate safety and tolerability of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)

1. Evaluate the Investigator’s assessment of clinical response at End-of-Therapy (EOT) visit in the MITT analysis set, 2. Evaluate the Investigator’s assessment of clinical response at D35 visit in the Clinically Evaluable (CE) at D35 (CE-D35) analysis set, 3. Per-subject microbiological response at D35, 4. Per-pathogen microbiological response at D35, 5. Per-pathogen microbiological response at EOT, 6. Composite endpoint of death, unplanned amputation, and infectious complications of the primary DFI by Day 35, 7. Evaluate early clinical response as equal or greater than 20% percent reduction in the surface area of redness, edema, and/or induration of the primary DFI site at Day 5 (± 1day), compared to Baseline, in patients who did not receive any rescue antibiotic therapy and are alive in the MITT analysis set.

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