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NCT05369052PHASE3Recruiting

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)

MicuRx

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interventions

DRUG

contezolid acefosamil (IV)/contezolid (PO)

DRUG

Linezolid (IV and PO)

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Conditions

Diabetic Foot Infection

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