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Taking people in United StatesPhase 3

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)

Key facts

Who runs it
MicuRx
Where
Corona and Vista, United StatesSee the 2 sitesAlso in 7 other countries, 12 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
865 people, planned
Started
3 May 2022
Expected to end
30 Jun 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • contezolid acefosamil (IV)/contezolid (PO)
  • Linezolid (IV and PO)
Record updated
13 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous DFI known or suspected to be caused by Gram-positive pathogens that are resistant to oxazolidinone antibiotics
  • Prior receipt of any formulation of contezolid acefosamil or contezolid
  • Evidence of significant hepatic, renal, hematologic, or immunologic disease
  • 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
  • Females who are pregnant or breastfeeding
  • 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

Where in United States

Also in 7 other countries, 12 sites

  • New Hope Research DevelopmentCorona, United StatesContact: Clinical coordinatorTaking people
  • ILD Research CenterVista, United StatesContact: Clinical coordinatorTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • contezolid acefosamil/contezolidTreatment being tested

    Treatment: contezolid acefosamil (IV)/contezolid (PO)

  • linezolidExisting treatment, for comparison

    Treatment: Linezolid (IV and PO)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Record updated
13 October 2026