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)
NCT ID: NCT05369052
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
865 participants
INTERVENTIONAL
2022-05-03
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
NCT03747497
Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)
NCT00229112
Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis
NCT04714411
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
NCT00366249
Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis
NCT02168816
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
contezolid acefosamil/contezolid
contezolid acefosamil (IV)/contezolid (PO)
Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)
linezolid
Linezolid (IV and PO)
Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
contezolid acefosamil (IV)/contezolid (PO)
Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)
Linezolid (IV and PO)
Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MicuRx
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
New Hope Research Development
Corona, California, United States
ILD Research Center
Vista, California, 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
JSC Vian - West Georgia Medical Center
Kutaisi, , Georgia
GMV Care& Research - Maria Cecilia Hospital
Cotignola, , Italy
Daugavpils Regional Hospital
Daugavpils, , Latvia
Instytut Medycyny Wsi im. W. Chodzki
Lublin, , Poland
PODEMA Sp. z o.o.
Warsaw, , Poland
University Clinical Center Kragujevac
Kragujevac, , Serbia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRXC-302
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.