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)
Start Date
5/3/2022
Completion Date
6/30/2026
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.
Detailed Description
Approximately 865 subjects (519 contezolid acefosamil/contezolid: 346 linezolid) will be enrolled with moderate or severe DFI that are confirmed or suspected to be due to a Gram-positive bacterial pathogen (MITT analysis set).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
contezolid acefosamil (IV)/contezolid (PO)
Linezolid (IV and PO)
Conditions
Locations
New Hope Research Development
Corona, California 92882
United States
ILD Research Center
Vista, California 92081
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