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 30, 2024
Sponsor: MicuRx
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

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

  • Hospital Italiano de Buenos Aires

    Buenos Aires,
    Argentina

    Site Not Available

  • Sanatorio Guemes

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Centro Universitario de Investigacion Clinica

    Corrientes,
    Argentina

    Site Not Available

  • Clinica Chutro

    Córdoba,
    Argentina

    Active - Recruiting

  • Hospital Rawson

    Córdoba,
    Argentina

    Site Not Available

  • Hospital San Roque

    Córdoba,
    Argentina

    Active - Recruiting

  • Instituto Medico Platense

    La Plata,
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar Del Plata,
    Argentina

    Active - Recruiting

  • Hospital Ernesto Dornelles

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Hospital Sao Lucas da PUCRS

    Porto Alegre,
    Brazil

    Site Not Available

  • Centro de Estudos e Pesquisas Em Molestias Infecciosas Ltda CPCLIN

    Rio Grande,
    Brazil

    Active - Recruiting

  • MHAT Blagoevgrad AD, Department of Surgery

    Blagoevgrad,
    Bulgaria

    Site Not Available

  • MHAT Sveti Nikolay Chudotvorets EOOD

    Lom,
    Bulgaria

    Active - Recruiting

  • UMHAT - Sveti Georgi EAD

    Plovdiv,
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment - KANEV

    Ruse,
    Bulgaria

    Active - Recruiting

  • Medical Institute Ministry of Interior Central Clinical Base

    Sofia,
    Bulgaria

    Active - Recruiting

  • UMHAT - Sofiamed

    Sofia,
    Bulgaria

    Active - Recruiting

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

    Sofia,
    Bulgaria

    Active - Recruiting

  • UMHAT - Prof. Stoyan Kirkovich

    Stara Zagora,
    Bulgaria

    Active - Recruiting

  • Biomedica Research Group

    Santiago,
    Chile

    Site Not Available

  • Hospital Gustavo Fricke

    Viña Del Mar,
    Chile

    Site Not Available

  • The Second Affiliated Hospital of Shantou University Medical Center

    Shantou, Guangdong
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Active - Recruiting

  • Hainan Medical College No. 2 Affiliated Hospital

    Haikou, Hainan
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • The Central Hospital of Wuhan

    Wuhan, Hubei
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University

    Wuhan, Hubei
    China

    Active - Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu
    China

    Active - Recruiting

  • Xi'an Medical University First Affiliated Hospital

    Xi'an, Shaanxi 710077
    China

    Active - Recruiting

  • West China Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Chongqing No. 4 People's Hospital

    Chongqing, Sichuan
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Sichuan
    China

    Active - Recruiting

  • Chu Hsien-I Memorial Hospital of Tianjin Medical University

    Tianjing, Tianjin
    China

    Active - Recruiting

  • Affiliated Hospital of Yunnan University

    Kunming, Yunnan
    China

    Active - Recruiting

  • General Hospital Slavonski Brod

    Slavonski Brod,
    Croatia

    Site Not Available

  • Clinical Hospital Merkur

    Zagreb,
    Croatia

    Site Not Available

  • Ida-Viru Central Hospital

    Kohtla-Järve,
    Estonia

    Active - Recruiting

  • Tartu University Hospital

    Tartu,
    Estonia

    Active - Recruiting

  • Viljandi Hospital

    Viljandi,
    Estonia

    Site Not Available

  • South-Estonian Hospital Ltd.

    Võru,
    Estonia

    Active - Recruiting

  • CH Tourcoing

    Tourcoing,
    France

    Site Not Available

  • LTD High Technology Hospital Med Center

    Batumi,
    Georgia

    Active - Recruiting

  • JSC Vian - West Georgia Medical Center

    Kutaisi,
    Georgia

    Active - Recruiting

  • Healthycore

    Tbilisi,
    Georgia

    Site Not Available

  • Tbilisi Heart Center

    Tbilisi,
    Georgia

    Active - Recruiting

  • General Hospital of Athens-Laiko

    Athens,
    Greece

    Site Not Available

  • ASST Fatebenefratelli Sacco-Ospedale Luigi Sacco - Polo Universitario

    Milano,
    Italy

    Site Not Available

  • AORN - Ospedali dei Colli - Ospedale D. Contugno

    Napoli,
    Italy

    Site Not Available

  • Daugavpils Regional Hospital

    Daugavpils,
    Latvia

    Active - Recruiting

  • Riga East Clinical University Hospital

    Riga,
    Latvia

    Active - Recruiting

  • Hospital of Lithuanian University of Health Sciences

    Kaunas,
    Lithuania

    Site Not Available

  • Klaipeda University Hospital

    Klaipėda,
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santaros Klimkos

    Vilnius,
    Lithuania

    Site Not Available

  • Hospital de CUF Descobertas Lisboa

    Lisboa,
    Portugal

    Site Not Available

  • Clinical Research Management Group, Inc.

    Mayagüez, 00780
    Puerto Rico

    Site Not Available

  • Clinical Research Management Group, Inc.

    Ponce, 00780
    Puerto Rico

    Site Not Available

  • Clinical Hospital Center Zvezdara

    Belgrade,
    Serbia

    Site Not Available

  • Institute of Cardiovascular Diseases Dedinje

    Belgrade,
    Serbia

    Active - Recruiting

  • Univerzitna Nemocnica Bratislava

    Bratislava,
    Slovakia

    Site Not Available

  • Fakultna Nemocnica Trnava

    Trnava,
    Slovakia

    Site Not Available

  • Hospital Universitario Donostia

    San Sebastián, Gipuzkoa 20014
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona,
    Spain

    Active - Recruiting

  • Perseverance Research Center. LLC

    Scottsdale, Arizona 85254
    United States

    Site Not Available

  • Velocity Clinical Research

    Chula Vista, California 91911
    United States

    Active - Recruiting

  • New Hope Research Development

    Corona, California 92882
    United States

    Active - Recruiting

  • Clemente Clinical Research

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California 90073
    United States

    Site Not Available

  • Sacramento VA Medical Center

    Mather, California 95655
    United States

    Site Not Available

  • Olive View UCLA Education & Research Institute

    Sylmar, California 91342
    United States

    Site Not Available

  • Harbor-UCLA Medical Center

    Torrance, California 90509
    United States

    Site Not Available

  • PIH Health Whittier Hospital

    Whittier, California 90602
    United States

    Site Not Available

  • University Medical and Research Center, LLC

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • University Medical and Research Center, LLC

    Miami, Florida 33134
    United States

    Active - Recruiting

  • Floridian Clinical Research, LLC

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Infectious Diseases Consultants of the Treasure Coast

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Aiyan Diabetes Center

    Augusta, Georgia 30907
    United States

    Site Not Available

  • Regional Infectious Diseases and Infusion Center, Inc.

    LaGrange, Georgia 30240
    United States

    Site Not Available

  • Michigan State University

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Billings Clinic Research

    Billings, Montana 59101
    United States

    Site Not Available

  • South Jersey Infectious Disease

    Somers Point, New Jersey 08244
    United States

    Active - Recruiting

  • Paddington Testing Company, Inc.

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • John Peter Smith Health Network

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Houston Foot and Ankle Care

    Houston, Texas 77027
    United States

    Site Not Available

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.