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Apr 24, 2020
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Exposure–Response Analyses to Support Optimal Dosing Regimens of Ceftolozane/Tazobactam in Patients With Hospital-Acquired Pneumonia (HAP)/Ventilator-Associated Pneumonia (VAP) in ASPECT-NP

Nosocomial pneumonia comprises hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) and is the most common nosocomial infection; mortality rates range from 3%–22% for nonventilated HAP (10%–40% for ventilated HAP) and from 6%–29% for VAP.

Ceftolozane/tazobactam (C/T), a combination of the antipseudomonal cephalosporin ceftolozane and the β-lactamase inhibitor tazobactam, is approved in the European Union and United States for the treatment of complicated intra-abdominal and urinary tract infections and HAP/VAP.

A 3-g C/T dose (2-g ceftolozane and 1-g tazobactam), or C/T dose adjusted based on renal function, was evaluated in patients with HAP/VAP in the phase 3 randomized, controlled, double-blind ASPECT-NP study (NCT02070757) – C/T was safe, and efficacy was noninferior to meropenem6.

An exposure–response analysis was performed to assess the potential relationship between ceftolozane and tazobactam plasma pharmacokinetics (PK) and clinical efficacy end points.

Presented at: the 30th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID); April 18-21 2020; Virtual.

By: Gao W, Julie Passarell, Yogesh T Patel, Zhang Z, Lin G, Jill Fiedler-Kelly, Bruno CJ, Rhee E, De Anda C, Feng HP

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