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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 3Ages 18 Years - anyAllMicuRx
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • contezolid acefosamil (IV)/contezolid (PO)
  • Linezolid (IV and PO)
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Where

14 sites
New Hope Research Development
Corona, United States
ILD Research Center
Vista, United States
MHAT Sveti Nikolay Chudotvorets EOOD
Lom, Bulgaria
Multiprofile Hospital for Active Treatment - KANEV
Rousse, Bulgaria
Medical Institute Ministry of Interior Central Clinical Base
Sofia, Bulgaria
University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´
Sofia, Bulgaria
South-Estonian Hospital Ltd.
Võru, Estonia
LTD High Technology Hospital Med Center
Batumi, Georgia

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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