Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections

Exclusion Criteria

• •All Participants:
• •Less than 18 years of age
• •History of hypersensitivity to ceftolozane/tazobactam, piperacillin/tazobactam, or any β-lactam antibiotic
• •History of hypersensitivity to lidocaine or lidocaine derivatives
• •Females who are pregnant or breastfeeding
• •Concomitant receipt of any β-lactams antibiotic
• •Concomitant receipt of probenecid
• •Reduced kidney function defined as creatinine clearance of ≤ 50 mL/min
• •Any other reason felt by the investigator to potentially affect the outcomes of the study
• •Experimental Group Only:
• •No palpable pedal pulses present
• •Participants likely to require multiple surgical interventions during the study period, which therefore could affect placement of the microdialysis catheter
• •Active Comparator Group Only:
• •Positive urine drug screen (cocaine, tetrahydrocannabinol, opiates, benzodiazepines, and amphetamines)
• •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
• •Use of tobacco- or nicotine-containing products in excess of the equivalence of 5 cigarettes per day.
• •Use of prescription or nonprescription drugs, vitamins, or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, with the exception of acetaminophen at doses of ≤ 1 g/day. Herbal supplements, hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing intrauterine devices (IUDs), postcoital contraceptive methods), and hormone replacement therapy must be discontinued at least 14 days prior to the first dose of study medication. Depo-Provera® must be discontinued at least 6 months prior to the first dose of study medication.