PIII RCT (NCT02070757; n=726) found high-dose ceftolozane–tazobactam was non-inferior to meropenem in terms of both 28-day all-cause mortality (24.0 vs. 25.3% died, respectively) and clinical cure at test of cure (54% vs 53%, respectively) for gram-negative nosocomial pneumonia in this population .
PII VECTOR study (NCT01853982) was electively terminated to focus on larger registrational study .
PIII ASPECT-NP study (n=726) meets pre-specified endpoints demonstrating non-inferiority of Zerbaxa to meropenem in day 28 all-cause mortality and clinical cure rate at test-of-cure visit .
NCT02070757 still recruiting pts. The estimated study completion date is now 2018 .
NCT02070757 currently recruiting patients. Collection of primary outcome should now complete September 2018 .
NCT01853982 was terminated in Jul 15 to focus on the larger PIII study; NCT02070757 is ongoing in the US and Europe and still recruiting patients. It is expected to complete Feb 18 .
NCT02070757 (ASPECT-NP) is a randomized, double-blind, multicentre, PIII study of IV ceftolozane/tazobactam vs meropenem in 726 adult patients with ventilated nosocomial pneumonia. The primary outcome is all-cause mortaility at day 28. The study starts Jun 14 and is due to complete Feb 18 .
NCT01853982: CXA-NP-11-08:(VECTOR) is a multicentre, open-label, randomized study of IV ceftolozane/tazobactam (8 hourly) with that of piperacillin/tazobactam (6 hourly) in 300 patients with ventilator associated pneumonia. The primary outcome is clinical response 24 hours after last dose of study drug in the mITT population. The study starts May 13 and is due to complete Jan 16 .
The FDA granted Qualified Infectious Disease Product (QIDP) designation for ceftolozane/tazobactam for the treatment of hospital-acquired bacterial pneumonia (HABP)/Ventilator-associated bacterial pneumonia (VABP) .