Comparing new antibiotics for treating diabetic foot infections
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)
PHASE3 · MicuRx · NCT05369052
This study is testing two new antibiotics to see if they can better treat moderate to severe foot infections in adults with diabetes compared to a standard antibiotic.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 865 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MicuRx (industry) |
| Locations | 14 sites (Corona, California and 13 other locations) |
| Trial ID | NCT05369052 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial evaluates the safety and efficacy of contezolid acefosamil administered intravenously and contezolid taken orally, compared to linezolid given both intravenously and orally, in adults with moderate to severe diabetic foot infections. Approximately 865 participants will be enrolled, with the study focusing on infections caused by Gram-positive bacteria. The treatment duration will range from 14 to 28 days, and the study will be conducted across multiple centers to ensure diverse participant representation.
Who should consider this trial
Good fit: Ideal candidates are adults with diabetes mellitus who have moderate or severe diabetic foot infections that meet specific clinical criteria.
Not a fit: Patients with diabetic foot infections caused by antibiotic-resistant bacteria or those with severe complications like osteomyelitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from diabetic foot infections.
How similar studies have performed: Other studies have shown promise in treating diabetic foot infections with similar antibiotic approaches, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Corona, California and 13 other locations
- New Hope Research Development — Corona, California, United States (RECRUITING)
- ILD Research Center — Vista, California, United States (RECRUITING)
- MHAT Sveti Nikolay Chudotvorets EOOD — Lom, Bulgaria (RECRUITING)
- Multiprofile Hospital for Active Treatment - KANEV — Rousse, Bulgaria (RECRUITING)
- Medical Institute Ministry of Interior Central Clinical Base — Sofia, Bulgaria (RECRUITING)
- University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´ — Sofia, Bulgaria (RECRUITING)
- South-Estonian Hospital Ltd. — Võru, Estonia (RECRUITING)
- LTD High Technology Hospital Med Center — Batumi, Georgia (RECRUITING)
- JSC Vian - West Georgia Medical Center — Kutaisi, Georgia (RECRUITING)
- GMV Care& Research - Maria Cecilia Hospital — Cotignola, Italy (RECRUITING)
- Daugavpils Regional Hospital — Daugavpils, Latvia (RECRUITING)
- Instytut Medycyny Wsi im. W. Chodzki — Lublin, Poland (RECRUITING)
- PODEMA Sp. z o.o. — Warsaw, Poland (RECRUITING)
- University Clinical Center Kragujevac — Kragujevac, Serbia (RECRUITING)
Study contacts
- Study coordinator: Clinical coordinator
- Email: info@micurx.com
- Phone: 510-782-2022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Foot Infection