TY - JOUR
T1 - Healthcare Resource Utilization of Ceftolozane/Tazobactam Versus Meropenem for Ventilated Nosocomial Pneumonia from the Randomized, Controlled, Double-Blind ASPECT-NP Trial
AU - Lodise, Thomas
AU - Yang, Joe
AU - Puzniak, Laura A.
AU - Dillon, Ryan
AU - Kollef, Marin
N1 - Funding Information:
Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA (MSD). MSD provided funding for the Rapid Service Fee.
Funding Information:
Laura Puzniak, Joe Yang, and Ryan Dillon are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD) and may own stock and/or hold stock options in Merck & Co., Inc., Kenilworth, NJ, USA. Marin Kollef reports advisory board and speaker’s bureau fees and institutional research funding from MSD. Dr Kollef is funded by the Barnes-Jewish Hospital Foundation. Thomas Lodise reports consulting and grant support from MSD.
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/12
Y1 - 2020/12
N2 - Introduction: Hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP) are associated with significant healthcare resource utilization (HCRU). This a priori, exploratory, secondary analysis from the ASPECT-NP clinical trial evaluated resource utilization among patients with ventilated HABP (vHABP)/VABP treated with ceftolozane/tazobactam or meropenem. Methods: This analysis used data from the randomized, double-blind, noninferiority phase 3 ASPECT-NP trial of patients with vHABP/VABP randomized to receive ceftolozane/tazobactam 3 g (ceftolozane 2 g/tazobactam 1 g) or meropenem 1 g for 8–14 days. Day 28 outcomes included hospital length of stay (LOS), intensive care unit (ICU) LOS, and time to mechanical ventilation extubation in the microbiological intention-to-treat (mITT) population and in an HCRU population. The HCRU population, a subset of patients from the mITT population that were alive at day 28, was used to remove resource use bias influenced by mortality rates. Results: Ceftolozane/tazobactam-treated versus meropenem-treated patients, respectively, had fewer deaths (20.1% vs. 25.5%), fewer hospital discharges (30.7% vs. 32.4%), and higher ICU discharges (60.0% vs. 58.3%) and extubations (51.9% vs. 48.2%) by day 28. In the HCRU population, adjusted LOS differences (95% confidence intervals) for ceftolozane/tazobactam compared with meropenem were 0.1 (− 1.4 to 1.6) hospitalization days, − 1.4 (− 2.9 to 0.2) ICU days, and − 0.9 (− 2.4 to 0.7) mechanical ventilation days. Patterns were similar among the VABP and Pseudomonas aeruginosa subgroups. Conclusion: Similar 28-day resource utilization outcomes were observed between ceftolozane/tazobactam and meropenem in the mITT population of patients from ASPECT-NP with vHABP/VABP due to gram-negative pathogens. ASPECT-NP was not powered to detect differences in resource utilization outcomes between treatment groups; however, numerical differences in ICU LOS and duration of mechanical ventilation were noted. Further study is needed to assess resource utilization in the real-world practice setting, especially among patients excluded from ASPECT-NP, including those with resistant P. aeruginosa infections. Trial Registrations: ClinicalTrials.gov: NCT02070757, registered February 25, 2014; EudraCT: 2012-002862-11.
AB - Introduction: Hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP) are associated with significant healthcare resource utilization (HCRU). This a priori, exploratory, secondary analysis from the ASPECT-NP clinical trial evaluated resource utilization among patients with ventilated HABP (vHABP)/VABP treated with ceftolozane/tazobactam or meropenem. Methods: This analysis used data from the randomized, double-blind, noninferiority phase 3 ASPECT-NP trial of patients with vHABP/VABP randomized to receive ceftolozane/tazobactam 3 g (ceftolozane 2 g/tazobactam 1 g) or meropenem 1 g for 8–14 days. Day 28 outcomes included hospital length of stay (LOS), intensive care unit (ICU) LOS, and time to mechanical ventilation extubation in the microbiological intention-to-treat (mITT) population and in an HCRU population. The HCRU population, a subset of patients from the mITT population that were alive at day 28, was used to remove resource use bias influenced by mortality rates. Results: Ceftolozane/tazobactam-treated versus meropenem-treated patients, respectively, had fewer deaths (20.1% vs. 25.5%), fewer hospital discharges (30.7% vs. 32.4%), and higher ICU discharges (60.0% vs. 58.3%) and extubations (51.9% vs. 48.2%) by day 28. In the HCRU population, adjusted LOS differences (95% confidence intervals) for ceftolozane/tazobactam compared with meropenem were 0.1 (− 1.4 to 1.6) hospitalization days, − 1.4 (− 2.9 to 0.2) ICU days, and − 0.9 (− 2.4 to 0.7) mechanical ventilation days. Patterns were similar among the VABP and Pseudomonas aeruginosa subgroups. Conclusion: Similar 28-day resource utilization outcomes were observed between ceftolozane/tazobactam and meropenem in the mITT population of patients from ASPECT-NP with vHABP/VABP due to gram-negative pathogens. ASPECT-NP was not powered to detect differences in resource utilization outcomes between treatment groups; however, numerical differences in ICU LOS and duration of mechanical ventilation were noted. Further study is needed to assess resource utilization in the real-world practice setting, especially among patients excluded from ASPECT-NP, including those with resistant P. aeruginosa infections. Trial Registrations: ClinicalTrials.gov: NCT02070757, registered February 25, 2014; EudraCT: 2012-002862-11.
KW - Ceftolozane/tazobactam
KW - Hospital-acquired bacterial pneumonia
KW - Hospitalization
KW - Mechanical ventilation
KW - Meropenem
KW - Multidrug resistance
KW - Pseudomonas aeruginosa
KW - Ventilator-associated bacterial pneumonia
UR - http://www.scopus.com/inward/record.url?scp=85091730339&partnerID=8YFLogxK
U2 - 10.1007/s40121-020-00343-0
DO - 10.1007/s40121-020-00343-0
M3 - Article
C2 - 32996064
AN - SCOPUS:85091730339
SN - 2193-8229
VL - 9
SP - 953
EP - 966
JO - Infectious Diseases and Therapy
JF - Infectious Diseases and Therapy
IS - 4
ER -