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)

Launched by MICURX · May 5, 2022

Keywords

ClinConnect Summary

This clinical trial is testing two new forms of a medication called contezolid, which is being compared to a standard treatment called linezolid. Both treatments are being given to adults with moderate to severe diabetic foot infections. The study aims to find out if contezolid is safe and effective for treating these types of infections. Participants will receive either the new medication or the standard treatment for 14 to 28 days, and the trial is currently recruiting individuals.

To join the study, participants need to have diabetes and a foot infection that started below the ankle and meets certain criteria for severity. They should not have had previous infections resistant to the treatments being tested or any other serious health issues. Throughout the trial, participants can expect regular check-ups to monitor their condition and treatment responses. It's important to know that women who are pregnant or breastfeeding cannot participate, and anyone unable to follow the study's requirements may also be excluded.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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