Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Exclusion criteria

• ✕. Less than 18 years of age
• ✕. History of hypersensitivity or allergy to tebipenem or its derivatives and any β-lactam antibiotic
• ✕. History of hypersensitivity to lidocaine or lidocaine derivatives
• ✕. Concurrently receiving probenecid.
• ✕. Males who are not surgically sterilized (with female partners of childbearing potential) and females of childbearing potential must agree to use two highly effective methods of contraception from screening, during this trial, and for 90 days after the last dose of study drug. A woman is considered of childbearing potential unless postmenopausal (≥1 year without menses) or surgically sterilized via bilateral oophorectomy, hysterectomy, bilateral tubal ligation, or successful Essure® placement with a documented confirmation test at least 90 days after the procedure. Highly effective contraception is defined as a method of contraception that has a less than 1% failure rate when used consistently and correctly. These methods are as follows:
• ✕. Any other documented reason felt by the investigator to potentially affect the outcomes of the study
• ✕. Participants likely to require multiple surgical interventions during the study period, which could affect placement of the microdialysis catheter
• ✕. Creatinine clearance (CrCl) \< 30ml/min, as calculated by Cockroft-Gault using ideal body weight