Frontlight ResearchEarly access
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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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