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)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Infection
• Intervention / Treatment: Drug: contezolid acefosamil (IV)/contezolid (PO); Drug: Linezolid (IV and PO)

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 865
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical coordinator; Phone Number: 510-782-2022; Email: info@micurx.com

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria
    • Recruiting
    • MHAT Blagoevgrad AD, Department of Surgery
  • Plovdiv, Bulgaria
    • Recruiting
    • UMHAT - Sveti Georgi EAD
  • Ruse, Bulgaria
    • Recruiting
    • Multiprofile Hospital for Active Treatment - KANEV
  • Sofia, Bulgaria
    • Recruiting
    • Medical Institute Ministry of Interior Central Clinical Base
  • Sofia, Bulgaria
    • Recruiting
    • UMHAT - Sofiamed
  • Stara Zagora, Bulgaria
    • Recruiting
    • UMHAT - Prof. Stoyan Kirkovich
• China
  • Guangdong
    • Shantou, Guangdong, China
      • Recruiting
      • The Second Affiliated Hospital of Shantou University Medical Center
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • The Second Affiliated Hospital of Guangxi Medical University
  • Hainan
    • Haikou, Hainan, China
      • Recruiting
      • Hainan Medical College No. 2 Affiliated Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The First Hospital Of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • The Central Hospital of Wuhan
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital Tongji Medical College Huazhong University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Zhongda Hospital Southeast University
    • Zhenjiang, Jiangsu, China
      • Recruiting
      • Affiliated Hospital of Jiangsu University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710077
      • Recruiting
      • Xi'an Medical University First Affiliated Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital
    • Chongqing, Sichuan, China
      • Recruiting
      • Chongqing No. 4 People's Hospital
    • Chongqing, Sichuan, China
      • Recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
  • Tianjin
    • Tianjing, Tianjin, China
      • Recruiting
      • Chu Hsien-I Memorial Hospital of Tianjin Medical University
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • Affiliated Hospital of Yunnan University
• Estonia
  • Kohtla-Järve, Estonia
    • Recruiting
    • Ida-Viru Central Hospital
  • Tartu, Estonia
    • Recruiting
    • Tartu University Hospital
  • Viljandi, Estonia
    • Recruiting
    • Viljandi Hospital
  • Võru, Estonia
    • Recruiting
    • South-Estonian Hospital Ltd.
• Greece
  • Athens, Greece
    • Recruiting
    • General Hospital of Athens-Laiko
• Italy
  • Napoli, Italy
    • Recruiting
    • AORN - Ospedali dei Colli - Ospedale D. Contugno
• Latvia
  • Daugavpils, Latvia
    • Recruiting
    • Daugavpils Regional Hospital
  • Riga, Latvia
    • Recruiting
    • Riga East Clinical University Hospital
• Lithuania
  • Kaunas, Lithuania
    • Recruiting
    • Hospital of Lithuanian University of Health Sciences
  • Vilnius, Lithuania
    • Recruiting
    • Vilnius University Hospital Santaros Klimkos
• Portugal
  • Lisboa, Portugal
    • Recruiting
    • Hospital de CUF Descobertas Lisboa
• Puerto Rico
  • Mayagüez, Puerto Rico, 00780
    • Recruiting
    • Clinical Research Management Group, Inc.
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Del Mar
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Recruiting
      • Perseverance Research Center. LLC
  • California
    • Chula Vista, California, United States, 91911
      • Recruiting
      • Velocity Clinical Research
    • Corona, California, United States, 92882
      • Recruiting
      • New Hope Research Development
    • Mather, California, United States, 95655
      • Recruiting
      • Sacramento VA Medical Center
    • Torrance, California, United States, 90509
      • Recruiting
      • Harbor-UCLA Medical Center
  • Florida
    • Miami, Florida, United States, 33134
      • Recruiting
      • University Medical and Research Center, LLC
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Floridian Clinical Research, LLC
  • Montana
    • Billings, Montana, United States, 59101
      • Recruiting
      • Billings Clinic Research
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
      • Recruiting
      • South Jersey Infectious Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: contezolid acefosamil/contezolid	Drug: contezolid acefosamil (IV)/contezolid (PO); Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)
Active Comparator: linezolid	Drug: Linezolid (IV and PO); Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators	Evaluate the Investigator's assessment of clinical response at EOT visit in the MITT analysis set	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	Evaluate the Investigator's assessment of clinical response at Day 10 (D10) and Late Follow-Up visits (LFU; 28-35 days after EOT) in the MITT analysis set	Day 10, 28-35 days after EOT

Collaborators and Investigators

• Sponsor: MicuRx

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Disease Attributes; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot; Infections; Communicable Diseases; Focal Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid
• Other Study ID Numbers: MRXC-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No