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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
EU CTIS ID: 2022-500257-16-00
What this study is testing
The primary objective is to evaluate the Investigator’s assessment of clinical response at the D35 visit in subjects receiving contezolid acefosamil/contezolid compared to subjects receiving linezolid in the MITT analysis set Evaluate safety and tolerability of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Males or females ≥18 years of age
- 2. Willing and able to provide written informed consent
- 3. Have diabetes mellitus (type 1 or 2) per the American Diabetes Association criteria
- 4. Have a foot infection that started at or below the malleolus and does not extend above the knee. If the subject has multiple infections that meet all the criteria below, the one with the highest IWGDF classification and the largest size will be designated as the primary DFI
- 5. Foot infection that meets the IWGDF DFI criteria for classification 3 (moderate infection) or 4 (severe infection) (Appendix 8) that are confirmed or suspected to be due to a Gram-positive bacterial pathogen
- 6. Foot infection had acute onset or worsening of signs and symptoms within the past 14 days
You likely can't join if
- 1. Previous DFI known or suspected to be caused by Gram-positive pathogens that are resistant to oxazolidinone antibiotics
- 18. Females who are pregnant or breastfeeding
- 19. Prior receipt of any formulation of contezolid acefosamil or contezolid
- 2. DFI with presumptive evidence or suspicion of osteomyelitis based on three diagnostic methods: X-ray, probe to bone test and erythrocyte sedimentation rate. Either an X-ray from the primary DFI site consistent with osteomyelitis, a positive probe to bone test, or an erythrocyte sedimentation rate (ESR) ≥70 mm/hour, will be evidence enough to suspect osteomyelitis (unless the ESR value only has any other plausible explanation such as rheumatologic disease, cancer, a large DFI infection, and the medical monitor approved such ESR value after his/her assessment). If osteomyelitis is diagnosed or suspected using methods different from those requested during this study (e.g., CT scan or MRI) such patients should not be enrolled either. EXCEPTION: if all infected bone was clearly removed (e.g., toe amputation) within 48 hours before the start of study drug administration but there remains infected soft tissue, the subject is acceptable for enrollment.
- 20. Prior (within the past 2 weeks) administration of, or expected or required concomitant (from the start of the study drug to EOT) administration of: a. Systemic adrenergic, dopaminergic, or serotonergic medications b. Monoamine oxidase inhibitors (eg, isocarboxazid, isoniazid, nialamide, phenelzine, procarbazine, and hydracarbazine)
- 22. Expected concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis
See the full eligibility criteria
Who can join
- 1. Males or females ≥18 years of age
- 2. Willing and able to provide written informed consent
- 3. Have diabetes mellitus (type 1 or 2) per the American Diabetes Association criteria
- 4. Have a foot infection that started at or below the malleolus and does not extend above the knee. If the subject has multiple infections that meet all the criteria below, the one with the highest IWGDF classification and the largest size will be designated as the primary DFI
- 5. Foot infection that meets the IWGDF DFI criteria for classification 3 (moderate infection) or 4 (severe infection) (Appendix 8) that are confirmed or suspected to be due to a Gram-positive bacterial pathogen
- 6. Foot infection had acute onset or worsening of signs and symptoms within the past 14 days
- 7. Received <48 hours administration of a potentially effective antibiotic (ie, active against all pathogens known to be present) to treat the current target infection within 96 hours before the start of study drug administration
- 8. Females must be either postmenopausal for ≥2 years or surgically sterile (having undergone tubal ligation, hysterectomy, or bilateral oophorectomy) or, if of childbearing potential, must have a negative pregnancy test at Screening/Baseline and, if sexually active with male partners, be willing to use a highly effective method of contraception throughout the study, such as 1 of the following: a. Hormonal contraception that inhibits the ovulation (stable dose for 3 months) b. Intrauterine device/intrauterine hormone- releasing system
- 9. Males, if nonsterile and sexually active with female partners of childbearing potential, must abstain from sexual intercourse or have partner(s) who will follow the contraception criteria for female study participants. Male must be willing to continue to use such highly effective birth control measures while participating in the study and for 60 days following participation in the study. Males must also refrain from sperm donations during this time.
What rules you out
- 1. Previous DFI known or suspected to be caused by Gram-positive pathogens that are resistant to oxazolidinone antibiotics
- 18. Females who are pregnant or breastfeeding
- 19. Prior receipt of any formulation of contezolid acefosamil or contezolid
- 2. DFI with presumptive evidence or suspicion of osteomyelitis based on three diagnostic methods: X-ray, probe to bone test and erythrocyte sedimentation rate. Either an X-ray from the primary DFI site consistent with osteomyelitis, a positive probe to bone test, or an erythrocyte sedimentation rate (ESR) ≥70 mm/hour, will be evidence enough to suspect osteomyelitis (unless the ESR value only has any other plausible explanation such as rheumatologic disease, cancer, a large DFI infection, and the medical monitor approved such ESR value after his/her assessment). If osteomyelitis is diagnosed or suspected using methods different from those requested during this study (e.g., CT scan or MRI) such patients should not be enrolled either. EXCEPTION: if all infected bone was clearly removed (e.g., toe amputation) within 48 hours before the start of study drug administration but there remains infected soft tissue, the subject is acceptable for enrollment.
- 20. Prior (within the past 2 weeks) administration of, or expected or required concomitant (from the start of the study drug to EOT) administration of: a. Systemic adrenergic, dopaminergic, or serotonergic medications b. Monoamine oxidase inhibitors (eg, isocarboxazid, isoniazid, nialamide, phenelzine, procarbazine, and hydracarbazine)
- 22. Expected concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis
- 23. Inability to tolerate a PO study drug for duration of study treatment (eg, nausea, vomiting, diarrhea, or any other condition that might impair ingestion or absorption of PO study drug)
- 24. Poor venous access
- 25. History of any intolerance, hypersensitivity, or allergic reaction to any oxazolidinone antibiotic or excipient in an oxazolidinone antibiotic
- 26. History of any intolerance, hypersensitivity, or allergic reaction to aztreonam or its excipients; note that while cross-reactivity of aztreonam with other β-lactams is rare, this drug should be administered with caution to any subject with a history of hypersensitivity to β-lactams (eg, penicillins, cephalosporins, carbapenems)
- 27. History of any intolerance, hypersensitivity, or allergic reaction to metronidazole or metronidazole excipient.
- 10. Receipt of chemotherapy, radiotherapy, or potent, noncorticosteroid immunosuppressant drugs (eg, cyclosporine, azathioprine, tacrolimus, immune-modulating monoclonal antibody therapy) within the past 3 months, or the receipt of corticosteroids ≥10 mg of prednisone (or equivalent) per day for >14 days in the prior 30 days
- 28. Taken any investigational drugs or used any investigational devices within 30 days or 5 half-lives of the study drug, whichever is longer, before randomization
- 29. 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
- 3. DFI without presumptive evidence of osteomyelitis anticipated to require >28 days of antibiotic treatment
- 4. 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
- 5. Infected prosthetic materials or devices at the primary DFI site that will not be removed before or at the time of enrollment
- 6. Anticipated requirement for complete resection or amputation (i.e., removal of all infected tissue with clean margins) of the infected DFI anatomical site within 30 days
- 7. Known or suspected concurrent infection of any type that would require treatment with a systemic antibacterial agent with activity against Gram-positive bacteria
- 8. Life expectancy <3 months or evidence of immediately life-threatening disease, including, but not limited to, current or impending respiratory failure, shock, acute coronary syndrome, unstable arrhythmias, hypertensive emergency, acute hepatic failure, active gastrointestinal bleeding, profound metabolic, or acute cerebrovascular events
- 9. Evidence of significant hepatic, renal, hematologic, or immunologic disease
- 11. Known or suspected pheochromocytoma or thyrotoxicosis or severe uncontrolled hypertension.
- 12. QT interval corrected for heart rate by Fridericia's formula (QTcF) duration >450 msec for males and >470 msec for females obtained as an average from the triplicate Screening/Baseline ECGs, history of QT prolongation, hypokalemia (serum potassium <3.0 mEq/L) at Screening/Baseline, or other proarrhythmic conditions
- 13. Concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed
- 14. History of known or suspected serotonin syndrome, neuroleptic malignant syndrome, or carcinoid syndrome
- 15. History of known or suspected Clostridioides difficile-associated diarrhea
- 16. History of drug-related peripheral or optic neuropathy (diabetic neuropathy is allowed)
- 17. History of a seizure disorder or known or suspected central nervous system condition that may predispose to seizures or lower the seizure threshold
The study team makes the final eligibility decision.
Where it's taking place
- United States
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.