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: October 10, 2026
Sponsor: MicuRx
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

Linezolid (IV and PO)

contezolid acefosamil (IV)/contezolid (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: Linezolid (IV and PO)
Phase: 3
Study Start date:
May 03, 2022
Estimated Completion Date:
June 30, 2027

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

  • MHAT Sveti Nikolay Chudotvorets EOOD

    Lom,
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment - KANEV

    Rousse,
    Bulgaria

    Active - Recruiting

  • Medical Institute Ministry of Interior Central Clinical Base

    Sofia,
    Bulgaria

    Active - Recruiting

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

    Sofia,
    Bulgaria

    Active - Recruiting

  • South-Estonian Hospital Ltd.

    Võru,
    Estonia

    Active - Recruiting

  • LTD High Technology Hospital Med Center

    Batumi,
    Georgia

    Active - Recruiting

  • JSC Vian - West Georgia Medical Center

    Kutaisi,
    Georgia

    Active - Recruiting

  • GMV Care& Research - Maria Cecilia Hospital

    Cotignola,
    Italy

    Active - Recruiting

  • Daugavpils Regional Hospital

    Daugavpils,
    Latvia

    Active - Recruiting

  • Instytut Medycyny Wsi im. W. Chodzki

    Lublin,
    Poland

    Active - Recruiting

  • PODEMA Sp. z o.o.

    Warsaw,
    Poland

    Active - Recruiting

  • University Clinical Center Kragujevac

    Kragujevac,
    Serbia

    Active - Recruiting

  • New Hope Research Development

    Corona, California 92882
    United States

    Active - Recruiting

  • ILD Research Center

    Vista, California 92081
    United States

    Active - Recruiting

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