Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients

Exclusion Criteria

• •1. History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication)
• •2. Prior (within 24 hours of first dose of study drug) or concomitant receipt of piperacillin/tazobactam or probenecid
• •3. History of lung transplant
• •4. Moderate to severe renal dysfunction defined as a creatinine clearance \< 50 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
• •5. A hemoglobin less than 8 gm/dl at baseline
• •6. Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
• •7. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
• •8. Planned or prior participation in any other interventional drug study within 30 days