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)

NCT05369052 | Recruiting Phase 3 FDA Drug

• 1 other identifier: MRXC-302
• Study Type: interventional
• Target: 865
• Locations: 8 countries
• Sites: 14

Brief 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.

Conditions

Diabetic Foot Infection

Outcome Measures

Primary Outcomes (4)

• Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators

  The primary objective is to evaluate the Investigator's assessment of clinical response at the D35 visit in subjects receiving contezolid acefosamil/contezolid compared to subjects receiving linezolid in the MITT analysis

  Day 35

• Adverse events - symptoms reported by subjects

  Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)

  28-35 days after End-of-Therapy (EOT)

• Clinical laboratory assessment - complete blood count

  Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)

  28-35 days after End-of-Therapy (EOT)

• Vital signs - heart rate

  Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)

  28-35 days after End-of-Therapy (EOT)

Secondary Outcomes (2)

• Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators

  14-28 days

• Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators

  Day 10, 28-35 days after EOT

Study Arms (2)

contezolid acefosamil/contezolid

EXPERIMENTAL

Drug: contezolid acefosamil (IV)/contezolid (PO)

linezolid

ACTIVE COMPARATOR

Drug: Linezolid (IV and PO)

Interventions

contezolid acefosamil (IV)/contezolid (PO) DRUG

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

contezolid acefosamil/contezolid

Linezolid (IV and PO) DRUG

Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)

linezolid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicuRx: lead

Study Sites (14)

New Hope Research Development

Corona, California, 92882, United States

RECRUITING

ILD Research Center

Vista, California, 92081, United States

RECRUITING

MHAT Sveti Nikolay Chudotvorets EOOD

Lom, Bulgaria

RECRUITING

Multiprofile Hospital for Active Treatment - KANEV

Rousse, Bulgaria

RECRUITING

Medical Institute Ministry of Interior Central Clinical Base

Sofia, Bulgaria

RECRUITING

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

Sofia, Bulgaria

RECRUITING

South-Estonian Hospital Ltd.

Võru, Estonia

RECRUITING

LTD High Technology Hospital Med Center

Batumi, Georgia

RECRUITING

JSC Vian - West Georgia Medical Center

Kutaisi, Georgia

RECRUITING

GMV Care& Research - Maria Cecilia Hospital

Cotignola, Italy

RECRUITING

Daugavpils Regional Hospital

Daugavpils, Latvia

RECRUITING

Instytut Medycyny Wsi im. W. Chodzki

Lublin, Poland

RECRUITING

PODEMA Sp. z o.o.

Warsaw, Poland

RECRUITING

University Clinical Center Kragujevac

Kragujevac, Serbia

RECRUITING

MeSH Terms

Interventions

Linezolid

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Clinical coordinator

CONTACT

510-782-2022; info@micurx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 11, 2022
• Study Start: May 3, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); GE (2); BU (4); LA (1); ES (1); US (2); PL (2); IT (1)