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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)
Sponsor: MicuRx
Summary
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.
Official title: A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
865
Start Date
2022-05-03
Completion Date
2026-06-30
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (14)
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