clinical trial · NCT05369052
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)
MicuRx·phase3·recruiting·n = 865
Diabetic Foot Infectioncontezolid acefosamil (IV)/contezolid (PO)Linezolid (IV and PO)
brief summary
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.
started
May 3, 2022
primary completion
Jun 30, 2026
completion
Jun 30, 2026
last updated
Sep 10, 2025
detailed description
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).
official title
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 (DFI)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol