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)
Recruiting now · Phase 3
Conditions studied: Diabetic Foot Infection
In brief
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.
Key facts
- Study ID
- NCT05369052
- Run by
- MicuRx
- People needed
- 865
- Starts
- 2022-05-03
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-09-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- New Hope Research Development — Corona, California, United States (enrolling)
- ILD Research Center — Vista, California, United States (enrolling)
- MHAT Sveti Nikolay Chudotvorets EOOD — Lom, Bulgaria (enrolling)
- Multiprofile Hospital for Active Treatment - KANEV — Rousse, Bulgaria (enrolling)
- Medical Institute Ministry of Interior Central Clinical Base — Sofia, Bulgaria (enrolling)
- University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´ — Sofia, Bulgaria (enrolling)
- South-Estonian Hospital Ltd. — Võru, Estonia (enrolling)
- LTD High Technology Hospital Med Center — Batumi, Georgia (enrolling)
- JSC Vian - West Georgia Medical Center — Kutaisi, Georgia (enrolling)
- GMV Care& Research - Maria Cecilia Hospital — Cotignola, Italy (enrolling)
- Daugavpils Regional Hospital — Daugavpils, Latvia (enrolling)
- Instytut Medycyny Wsi im. W. Chodzki — Lublin, Poland (enrolling)
- PODEMA Sp. z o.o. — Warsaw, Poland (enrolling)
- University Clinical Center Kragujevac — Kragujevac, Serbia (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.