New NICE guidance evidence review on the use of ceftolozane with tazobactam

  • NICE
  • NICE
  • 18 Dec 2019

  • curated by Priscilla Lynch
  • Medical News
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

NICE has published a new guidance evidence review on the use of ceftolozane with tazobactam for treating hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

Ceftolozane with tazobactam is a combination of a cephalosporin antibiotic, which predominantly covers Gram-negative bacteria, and a beta-lactamase inhibitor, which inhibits many (but not all) class A beta-lactamases. It is given as a one-hour intravenous (IV) infusion every 8 hours.

Ceftolozane with tazobactam received a marketing authorisation for treating complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary tract infections in adults in September 2015. In August 2019, the indication for ceftolozane with tazobactam was extended to include treating HAP, including VAP in adults.

Evidence for using ceftolozane with tazobactam for treating HAP and VAP is from one phase 3 randomised controlled non-inferiority trial (ASPECT-NP), said NICE. ASPECT-NP found that a high dose of ceftolozane with tazobactam was non-inferior to meropenem for treating seriously ill people with VAP or ventilated HAP caused by Gram-negative pathogens such as Pseudomonas aeruginosa (including multidrug-resistant strains) and Enterobacterales. Rates of 28-day mortality and clinical cure were similar between the treatment groups, and findings in the intention-to-treat (ITT) population were supported by sensitivity and per-protocol analyses.

Ceftolozane with tazobactam was generally well-tolerated. However, limited safety data are available for the high dose used in this study, which is recommended for HAP and VAP.

Specialists involved in producing this evidence summary consider that ceftolozane with tazobactam provides a potentially useful alternative for treating some adults with HAP and VAP who have limited treatment options because they have infections suspected or proven to be caused by Enterobacterales (excluding carbapenem-resistant bacteria) or multidrug-resistant Pseudomonas aeruginosa.

Local antibiotic resistance patterns will need to be taken into account, added NICE.