Contezolid Acefosamil and Contezolid Compared to Linezolid in DFI
Research type
Research Study
Full 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
IRAS ID
1006722
Contact name
Regis Vilchez
Contact email
Sponsor organisation
MicuRx Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
Diabetic foot infection (DFI) is caused by germs called bacteria, which enter the body through open wounds like skin ulcers and cuts. When bacteria reproduce faster than the body’s immune system can keep up with them, an infection develops. People with diabetes, especially those who have had diabetes for a long time, are more likely to develop infections due to sores and cuts on their feet.
Typically, a doctor prescribes a drug called an antibiotic to bring the bacteria back under control. Over time, bacteria can develop resistance to the antibiotics used to treat DFIs, and those antibiotics stop working against those bacteria. It is important to create new antibiotics so that we have other options when this happens.
The goal of the study is to find out whether the investigational study drug, contezolid acefosamil and contezolid, developed by MicuRx Pharmaceuticals, can improve DFIs with similar efficacy and with fewer side effects than an approved drug, linezolid. Both drugs used in the study are antibiotics that can be started during the early stage of a serious DFI.
There will be two groups of subjects with DFI treated in this study:
• In Group A, subjects will receive contezolid acefosamil directly into a vein (intravenous or “IV”) and then contezolid tablets only at the investigator’s discretion
• In Group B, subjects will receive linezolid IV and then tablets only at the investigator’s discretion:
The study drugs, contezolid acefosamil (IV) and contezolid (tablets) or linezolid (IV and tablets), will be administered for a total of 14 to 28 days (28 to 56 doses).
The objectives of this study are to compare contezolid acefosamil/contezolid to linezolid in treating DFIs that are confirmed or suspected to be caused by Gram-positive bacteria.
Approximately 865 participants will take part in this study at approximately 75 study sites worldwide.REC name
South Central - Oxford C Research Ethics Committee
REC reference
23/SC/0220
Date of REC Opinion
6 Oct 2023
REC opinion
Further Information Favourable Opinion