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)

Last updated: September 9, 2025
Sponsor: MicuRx
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

contezolid acefosamil (IV)/contezolid (PO)

Linezolid (IV and PO)

Clinical Study ID

NCT05369052
MRXC-302
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 extendabove the knee

  • Foot infection that meets the IWGDF DFI criteria for classification 3 (moderateinfection) or 4 (severe infection)

  • Foot infection had acute onset or worsening of signs and symptoms within the past 14days

Exclusion

Exclusion Criteria:

  • Previous DFI known or suspected to be caused by Gram-positive pathogens that areresistant to oxazolidinone antibiotics

  • DFI with presumptive evidence or suspicion of osteomyelitis

  • Necrotizing fasciitis, crepitant cellulitis, wet gangrene, gas gangrene, ecthymagangrenosum, septic arthritis, or severely impaired arterial supply to any portionof 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, includingthe schedule of events, or likely to be noncompliant with any study requirements, orthe Investigator determines that the subject should not participate in the study

Study Design

Total Participants: 865
Treatment Group(s): 2
Primary Treatment: contezolid acefosamil (IV)/contezolid (PO)
Phase: 3
Study Start date:
May 03, 2022
Estimated Completion Date:
June 30, 2026

Study 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).

Connect with a study center

  • Sanatorio Guemes

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Clinica Chutro

    Córdoba,
    Argentina

    Active - Recruiting

  • Hospital Rawson

    Córdoba,
    Argentina

    Site Not Available

  • Hospital Sao Lucas da PUCRS

    Porto Alegre,
    Brazil

    Site Not Available

  • MHAT Sveti Nikolay Chudotvorets EOOD

    Lom 729581,
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment - KANEV

    Rousse 727523,
    Bulgaria

    Active - Recruiting

  • Medical Institute Ministry of Interior Central Clinical Base

    Sofia,
    Bulgaria

    Active - Recruiting

  • UMHAT - Sofiamed

    Sofia,
    Bulgaria

    Active - Recruiting

  • Medical Institute Ministry of Interior Central Clinical Base

    Sofia 727011,
    Bulgaria

    Active - Recruiting

  • University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´

    Sofia 727011,
    Bulgaria

    Active - Recruiting

  • The Central Hospital of Wuhan

    Wuhan, Hubei
    China

    Active - Recruiting

  • West China Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Sichuan
    China

    Active - Recruiting

  • South-Estonian Hospital Ltd.

    Võru 587450,
    Estonia

    Active - Recruiting

  • LTD High Technology Hospital Med Center

    Batumi 615532,
    Georgia

    Active - Recruiting

  • JSC Vian - West Georgia Medical Center

    Kutaisi 613607,
    Georgia

    Active - Recruiting

  • Healthycore

    Tbilisi,
    Georgia

    Site Not Available

  • GMV Care& Research - Maria Cecilia Hospital

    Cotignola 3177876,
    Italy

    Active - Recruiting

  • Daugavpils Regional Hospital

    Daugavpils 460413,
    Latvia

    Active - Recruiting

  • Instytut Medycyny Wsi im. W. Chodzki

    Lublin 765876,
    Poland

    Active - Recruiting

  • PODEMA Sp. z o.o.

    Warsaw 756135,
    Poland

    Active - Recruiting

  • Institute of Cardiovascular Diseases Dedinje

    Belgrade,
    Serbia

    Active - Recruiting

  • University Clinical Center Kragujevac

    Kragujevac 789128,
    Serbia

    Active - Recruiting

  • Clemente Clinical Research

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Harbor-UCLA Medical Center

    Torrance, California 90509
    United States

    Active - Recruiting

  • New Hope Research Development

    Corona 5339631, California 5332921 92882
    United States

    Active - Recruiting

  • ILD Research Center

    Vista 5406602, California 5332921 92081
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.