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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)

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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 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

About the study

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.

What is being tested

Sponsor: MicuRx · Participants: 865 · Started: May 3, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05369052

Locations in the U.S.

CaliforniaNew Hope Research Development, Corona
ILD Research Center, Vista

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.