Clinical efficacy of ZERBAXA® (ceftolozane and tazobactam) against HABP/VABP
Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)
ZERBAXA was studied in critically ill patients.
Primary efficacy endpoint: all-cause mortality at day 28. Objective was to demonstrate the noninferiority of ZERBAXA versus meropenem in adults with HABP/VABP. For analysis of the overall treatment differences, 2-sided 95% confidence intervals (Cls) were calculated as stratified Newcombe Cls.
100% of patients in the trial were ventilated
Current antibiotic failure
Approximately 13% of patients were failing current antibacterial therapy for HABP/VABP
APACHE II score
Patients had a median baseline APACHE II score of 17, indicating a 24% mortality rate (1/3 of patients had a score of ≥20, a 40% mortality rate)1,2
Hospitalized for ≥5 days
77% of patients had been hospitalized for ≥5 days, 92% in the ICU
In a Phase 3 study, ZERBAXA achieved primary endpoint of noninferiority to meropenem in day 28 all-cause mortality1.
The analysis population for the primary endpoint was the ITT population, which included all randomized patients
- In the vHABP subgroup of patients (~28.5%), there was a favorable response for ZERBAXA in all-cause mortality through day 28.
- In the VABP subgroup, day 28 all-cause mortality was 24.0% (63/263) for ZERBAXA and 20.3% (52/256) for meropenem
1. Kollef MH, Nováček M, Kivistik Ü, et al. Ceftolozane-tazobactam versus meropenem for treatment of nosocomial pneumonia (ASPECT-NP): a randomised, controlled, doubleblind, phase 3, non-inferiority trial. Lancet Infect Dis. 2019;19(12):1299-1311.
2. APACHE II Calculator: Acute Physiology and Chronic Health Evaluation (APACHE) II score to predict hospital mortality. Updated November 10, 2018. Accessed July 29, 2022.