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)

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.

Conditions

Diabetic Foot Infection

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Study Overview

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Study Details

Study overview

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.

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)

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)

Condition
Diabetic Foot Infection
Intervention / Treatment

-

Contacts and Locations

Chula Vista

Velocity Clinical Research, Chula Vista, California, United States, 91911

Corona

New Hope Research Development, Corona, California, United States, 92882

Los Angeles

Clemente Clinical Research, Los Angeles, California, United States, 90033

Los Angeles

VA Greater Los Angeles Healthcare System, Los Angeles, California, United States, 90073

Sylmar

Olive View UCLA Education & Research Institute, Sylmar, California, United States, 91342

Whittier

PIH Health Whittier Hospital, Whittier, California, United States, 90602

Miami Lakes

Floridian Clinical Research, LLC, Miami Lakes, Florida, United States, 33016

Miami

University Medical and Research Center, LLC, Miami, Florida, United States, 33134

Vero Beach

Infectious Diseases Consultants of the Treasure Coast, Vero Beach, Florida, United States, 32960

East Lansing

Michigan State University, East Lansing, Michigan, United States, 48824

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MicuRx,

Study Record Dates

2026-06-30