Comparing new antibiotics for treating diabetic foot infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial evaluates the safety and efficacy of contezolid acefosamil administered intravenously and contezolid taken orally, compared to linezolid given both intravenously and orally, in adults with moderate to severe diabetic foot infections. Approximately 865 participants will be enrolled, with the study focusing on infections caused by Gram-positive bacteria. The treatment duration will range from 14 to 28 days, and the study will be conducted across multiple centers to ensure diverse participant representation.

Why it matters

Who can join: the full rules

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

Where it's running

• New Hope Research Development
  Corona, California, United States Recruiting
• ILD Research Center
  Vista, California, United States Recruiting
• MHAT Sveti Nikolay Chudotvorets EOOD
  Lom, Bulgaria Recruiting
• Multiprofile Hospital for Active Treatment - KANEV
  Rousse, Bulgaria Recruiting
• Medical Institute Ministry of Interior Central Clinical Base
  Sofia, Bulgaria Recruiting
• University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´
  Sofia, Bulgaria Recruiting

Study contacts

• Study coordinator: Clinical coordinator
• Email: info@micurx.com
• Phone: 510-782-2022

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.