This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.
Have diabetes mellitus (type 1 or 2) per the American Diabetes Association criteria
Have a foot infection that started at or below the malleolus and does not extend above the knee
Foot infection that meets the IWGDF DFI criteria for classification 3 (moderate infection) or 4 (severe infection)
Foot infection had acute onset or worsening of signs and symptoms within the past 14 days
Previous DFI known or suspected to be caused by Gram-positive pathogens that are resistant to oxazolidinone antibiotics
DFI with presumptive evidence or suspicion of osteomyelitis
Necrotizing fasciitis, crepitant cellulitis, wet gangrene, gas gangrene, ecthyma gangrenosum, septic arthritis, or severely impaired arterial supply to any portion of the affected foot which may need revascularization before the end of the study
Evidence of significant hepatic, renal, hematologic, or immunologic disease