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RECRUITING
NCT05369052
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

contezolid acefosamil (IV)/contezolid (PO)

Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)

DRUG

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