RECRUITING

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)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2022-05-03

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05369052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Clinical coordinator

CONTACT

510-782-2022

info@micurx.com

Study Locations (Sites)

Velocity Clinical Research

Chula Vista, California, 91911

United States

New Hope Research Development

Corona, California, 92882

United States

Clemente Clinical Research

Los Angeles, California, 90033

United States

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073

United States

Olive View UCLA Education & Research Institute

Sylmar, California, 91342

United States

PIH Health Whittier Hospital

Whittier, California, 90602

United States

Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016

United States

University Medical and Research Center, LLC

Miami, Florida, 33134

United States

Infectious Diseases Consultants of the Treasure Coast

Vero Beach, Florida, 32960

United States

Michigan State University

East Lansing, Michigan, 48824

United States

South Jersey Infectious Disease

Somers Point, New Jersey, 08244

United States

John Peter Smith Health Network

Fort Worth, Texas, 76104

United States

Collaborators and Investigators

Sponsor: MicuRx

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-03

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-05-03

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Foot Infection