New Antibiotics vs Linezolid for Diabetic Foot Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new antibiotics to determine if they are more effective and safer than the current treatment, linezolid, for foot infections in people with diabetes. The focus is on moderate to severe infections that began or worsened in the last two weeks. People with diabetes and a recent foot infection below the knee might be suitable for this study. The trial includes two groups: one will receive the new antibiotics, contezolid acefosamil/contezolid, and the other will receive linezolid. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that contezolid acefosamil and contezolid are generally safe. In earlier studies, patients with moderate-to-severe diabetic foot infections tolerated these treatments well. Notably, contezolid may cause fewer bone marrow issues, which is crucial for blood cell production, compared to other treatments, especially with long-term use. This suggests that contezolid could be a safer option for extended treatment.
For those considering joining a clinical trial, it is reassuring that contezolid's safety has been tested in people with similar conditions, providing some confidence in its safety for treating diabetic foot infections. However, discussing any concerns with a doctor is always advisable.12345Why do researchers think this study treatment might be promising for diabetic foot infections?
Researchers are excited about contezolid acefosamil/contezolid for diabetic foot infections because it offers a potential new approach to fighting bacteria. While standard treatments like linezolid target bacterial protein synthesis, contezolid acefosamil/contezolid is designed to be effective against resistant strains and may have a better safety profile, especially concerning side effects like bone marrow suppression. This new treatment could provide a crucial alternative for patients who experience adverse effects or inadequate results with existing antibiotics.
What evidence suggests that this trial's treatments could be effective for diabetic foot infections?
In this trial, participants will receive either contezolid acefosamil/contezolid or linezolid to treat diabetic foot infections. Research has shown that contezolid acefosamil and contezolid hold promise for treating these infections. Studies have found these antibiotics safe and effective for moderate to severe cases. Specifically, one study noted that patients responded well to contezolid, similar to linezolid, a commonly used antibiotic for this condition. These findings suggest contezolid could serve as a strong alternative for treating diabetic foot infections. Overall, early evidence supports its potential effectiveness in managing this challenging infection.23567
Are You a Good Fit for This Trial?
Adults with moderate or severe diabetic foot infections who have diabetes mellitus (type 1 or 2), an infection that meets specific criteria, and a recent onset of symptoms can join. Those with significant organ diseases, previous resistant infections, suspected bone infections, pregnant/breastfeeding women, noncompliance risk, or certain severe conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive contezolid acefosamil/contezolid or linezolid for 14 to 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Contezolid Acefosamil/Contezolid
- Linezolid
Contezolid Acefosamil/Contezolid is already approved in China for the following indications:
- Complicated skin and soft tissue infections (cSSTIs)
Find a Clinic Near You
Who Is Running the Clinical Trial?
MicuRx
Lead Sponsor