MicuRx
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.
Approximately 865 subjects (519 contezolid acefosamil/contezolid: 346 linezolid) will be enrolled with moderate or severe DFI that are confirmed or suspected to be due to a Gram-positive bacterial pathogen (MITT analysis set).
Inclusion Criteria: * 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 Exclusion Criteria: * Previous DFI known or suspected to be caused by Gram-positive pathogens that are resistant to oxazolidinone antibiotics * DFI with presumptive evidence or suspici…
Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)
Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)