Actively Recruiting
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)
Led by MicuRx · Updated on 2025-09-10
865
Participants Needed
14
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Previous diabetic foot infection known or suspected to be caused by Gram-positive pathogens resistant to oxazolidinone antibiotics
- Diabetic foot infection 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 needing revascularization before study end
- Evidence of significant liver, kidney, blood, or immune system disease
- Females who are pregnant or breastfeeding
- Prior receipt of any formulation of contezolid acefosamil or contezolid
- Inability to fully cooperate with study protocol requirements or likely to be noncompliant, or Investigator determines subject should not participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
New Hope Research Development
Corona, California, United States, 92882
Actively Recruiting
2
ILD Research Center
Vista, California, United States, 92081
Actively Recruiting
3
MHAT Sveti Nikolay Chudotvorets EOOD
Lom, Bulgaria
Actively Recruiting
4
Multiprofile Hospital for Active Treatment - KANEV
Rousse, Bulgaria
Actively Recruiting
5
Medical Institute Ministry of Interior Central Clinical Base
Sofia, Bulgaria
Actively Recruiting
6
University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´
Sofia, Bulgaria
Actively Recruiting
7
South-Estonian Hospital Ltd.
Võru, Estonia
Actively Recruiting
8
LTD High Technology Hospital Med Center
Batumi, Georgia
Actively Recruiting
9
JSC Vian - West Georgia Medical Center
Kutaisi, Georgia
Actively Recruiting
10
GMV Care& Research - Maria Cecilia Hospital
Cotignola, Italy
Actively Recruiting
11
Daugavpils Regional Hospital
Daugavpils, Latvia
Actively Recruiting
12
Instytut Medycyny Wsi im. W. Chodzki
Lublin, Poland
Actively Recruiting
13
PODEMA Sp. z o.o.
Warsaw, Poland
Actively Recruiting
14
University Clinical Center Kragujevac
Kragujevac, Serbia
Actively Recruiting
Research Team
C
Clinical coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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