- In critically ill patients with nosocomial pneumonia, high-dose ceftolozane-tazobactam was non-inferior to meropenem in terms of 28-day mortality and clinical response.
Why this matters
- Findings suggest that high-dose ceftolozane-tazobactam can be used for the treatment of nosocomial pneumonia caused by P aeruginosa, Enterobacteriaceae, and other Gram-negative lower respiratory tract pathogens.
- Patients with nosocomial pneumonia were randomly assigned to receive ceftolozane-tazobactam (3 g; n=361) and meropenem (1 g; n=359).
- Primary outcome: 28-day all-cause mortality.
- Secondary outcome: clinical response at the test-of-cure visit.
- Funding: MSD.
- Overall, 519 (71.50%) patients had ventilator-associated pneumonia, 207 (28.5%) had ventilated hospital-acquired pneumonia, 239 (33%) had Acute Physiology and Chronic Health Evaluation II scores ≥20 and 668 (92%) were in the intensive care unit.
- Ceftolozane-tazobactam was non-inferior to meropenem in terms of:
- 28-day all-cause mortality (24.0% vs 25.3%; weighted treatment difference, 1.1%; 95% CI, −5.1 to 7.4).
- clinical response at the test-of-cure visit (54.4% vs 53.3%; weighted treatment difference, 1.1%; 95% CI, −6.2 to 8.3).
- Treatment-related adverse events were reported in 38 (11%) patients in the ceftolozane-tazobactam group and 27 (8%) in the meropenem group.
- Serious treatment-related adverse events occurred in 8 (2%) patients in the ceftolozane-tazobactam group and 2 (1%) in the meropenem group.
- No treatment-related deaths were reported in both groups.
- Immunosuppressed patients, patients with cystic fibrosis and those receiving dialysis were excluded.