Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sylmar, California and other locations
Dates
study started
completion around

Description

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.

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)

Details

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).

Keywords

Diabetic Foot Infection, Infections, Communicable Diseases, Focal Infection, Diabetic Foot, Linezolid, contezolid acefosamil (IV)/contezolid (PO), Linezolid (IV and PO), contezolid acefosamil/contezolid

Eligibility

Locations

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
MicuRx
ID
NCT05369052
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 865 study participants
Last Updated