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

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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
  • Females who are pregnant or breastfeeding
  • Prior receipt of any formulation of contezolid acefosamil or contezolid
  • Inability to cooperate fully with the requirements of the study protocol, including the schedule of events, or likely to be noncompliant with any study requirements, or the Investigator determines that the subject should not participate in the study

Locations

  • Olive View UCLA Education & Research Institute in progress, not accepting new patients
    Sylmar California 91342 United States
  • Clemente Clinical Research accepting new patients
    Los Angeles California 90033 United States
  • VA Greater Los Angeles Healthcare System in progress, not accepting new patients
    Los Angeles California 90073 United States
  • PIH Health Whittier Hospital in progress, not accepting new patients
    Whittier California 90602 United States
  • New Hope Research Development accepting new patients
    Corona California 92882 United States

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