Ongoing Clinical Trials for Diabetic Foot Infection
There is currently 1 ongoing clinical trial investigating new treatment options for diabetic foot infection. This trial is being conducted across 15 European countries and is comparing the effectiveness and safety of two newer medications, Contezolid Acefosamil and Contezolid, against the established treatment Linezolid. The study focuses on adults with moderate or severe infections that occur in the feet of people with diabetes.
Clinical trial locations
- Bulgaria
- Croatia
- Czechia
- Estonia
- France
- Greece
- Hungary
- Italy
- Latvia
- Lithuania
- Poland
- Portugal
- Romania
- Slovakia
- Spain
Study on the Safety and Effectiveness of Contezolid Acefosamil, Contezolid, and Linezolid for Adults with Moderate or Severe Diabetic Foot Infections
This trial is investigating the treatment of infections that occur in the feet of people with diabetes. These infections happen when wounds or ulcers on the feet become infected with bacteria, causing symptoms like redness, swelling, warmth, and sometimes pus formation. If left untreated, the infection can spread to deeper tissues, muscles, and even bones, leading to serious complications.
Main focus of the trial: The study aims to compare the effectiveness and safety of two newer medications, Contezolid Acefosamil and Contezolid, against Linezolid, which is an already established antibiotic used for treating bacterial infections. The trial will last up to 28 days, during which participants will receive treatment and be closely monitored by the study team. Researchers want to determine if the new medications work as well as or better than Linezolid in clearing the infection while also checking for any side effects.
Investigational drugs: Contezolid Acefosamil is given through an intravenous infusion directly into the bloodstream. It works by targeting and stopping the growth of bacteria. Contezolid is taken orally as a pill and functions similarly by preventing bacteria from growing. Both of these medications are still being tested and are not yet widely available. Linezolid, the comparison medication, can be given both intravenously and orally, and it works by stopping bacteria from producing the proteins they need to survive and multiply.
Who can participate: To join this trial, participants must be at least 18 years old and have either type 1 or type 2 diabetes. They need to have a foot infection that started at or below the ankle and is classified as moderate or severe. The infection should be suspected to be caused by Gram-positive bacteria and must have started or worsened within the last 14 days. Participants must not have taken more than 48 hours of effective antibiotic treatment in the 96 hours before starting the study medication. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study. Men who are sexually active with women who can have children must also use birth control methods and agree not to donate sperm during the study and for 60 days after.
Who cannot participate: The trial excludes patients who have other serious infections not related to their foot infection, those who have had allergic reactions to similar medications, and anyone currently participating in another clinical trial. People with severe liver or kidney disease, pregnant or breastfeeding women, and those with compromised immune systems cannot join. Additionally, patients who have recently used certain antibiotics that might interfere with the study medication, those with a history of alcohol or drug abuse, and individuals with conditions that might affect how oral medications are absorbed are excluded. People with mental health conditions that could affect their ability to follow study instructions are also not eligible.
What to expect during the trial: Upon joining, participants will be randomly assigned to receive either Contezolid Acefosamil or Linezolid. This is a double-blind study, meaning neither participants nor the study team will know which medication is being given. Treatment begins with the assigned medication, either through intravenous infusion or orally, depending on the specific treatment plan. After the initial phase, participants may switch to oral medication in tablet form. Throughout the study, regular visits will take place to monitor health, response to treatment, and any side effects. At the end of the treatment period, a final evaluation will assess the effectiveness of the medication and overall health.
Summary
Currently, there is one active clinical trial focused on diabetic foot infections, spanning 15 European countries including Croatia, Romania, Lithuania, Bulgaria, Spain, Estonia, Italy, Latvia, Greece, France, Hungary, Czechia, Slovakia, Portugal, and Poland. This wide geographic distribution reflects a collaborative effort to evaluate new treatment options across diverse patient populations.
The trial is specifically investigating two novel antibiotic medications, Contezolid Acefosamil and Contezolid, comparing them against the established treatment Linezolid. All three medications target bacterial infections, which are a major concern in diabetic foot complications. The study’s design allows for both intravenous and oral administration, providing flexibility in treatment approaches for patients with moderate to severe infections.
This research is particularly important for people with diabetes who develop foot infections, as these infections can lead to serious complications if not properly managed. The trial’s focus on comparing new medications with existing treatments may help identify more effective or better-tolerated options for patients in the future.
