Recruiting
Phase 3

Contezolid & Linezolid

Sponsor:

MicuRx

Code:

NCT05369052

Conditions

Diabetic Foot Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

contezolid acefosamil (IV)/contezolid (PO)

Linezolid (IV and PO)

Study Details

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.

Conditions

Diabetic Foot Infection

Study ID

NCT05369052

Start date

May 3, 2022

Status verified date

Sep, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

865 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: contezolid acefosamil/contezolid

active comparator: linezolid

Interventions

contezolid acefosamil (IV)/contezolid (PO)

Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)

Linezolid (IV and PO)

Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)

Primary outcome measure

  • Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators [ Time Frame: Day 35 ]
  • Adverse events - symptoms reported by subjects [ Time Frame: 28-35 days after End-of-Therapy (EOT) ]
  • Clinical laboratory assessment - complete blood count [ Time Frame: 28-35 days after End-of-Therapy (EOT) ]
  • Vital signs - heart rate [ Time Frame: 28-35 days after End-of-Therapy (EOT) ]

Central Contacts and Locations

Central contacts

Clinical coordinator

510-782-2022info@micurx.com

Locations

New Hope Research Development

Recruiting

Corona, California, United States, 92882

ILD Research Center

Recruiting

Vista, California, United States, 92081

More Information

Sponsor

MicuRx

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MicuRx on 2025-09-10.