Merck has reported positive results from the ASPECT-NP study, after meeting the trial’s primary objectives of all-cause mortality at day 28 and in-clinical cure rate at the test-of-cure visit.
ASPECT-NP is a Phase lll trial that evaluated the safety and efficacy of Zerbaxa (ceftolozane and tazobactam) in comparison with meropenem to treat adult patients with either ventilated hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).
The prospective, randomised, double-blind, multicentre, non-inferiority trial included 726 patients with either ventilated HABP or VABP requiring intravenous antibiotic therapy.
During the trial, the patients received 3g of Zerbaxa and 1g meropenem, each of which were given intravenously every eight hours for eight to 14 days, or for 14 days for Pseudomonas aeruginosa infection.
Results from the trial have demonstrated the non-inferiority of Zerbaxa to meropenem, which is an approved broad-spectrum injectable antibiotic used to treat serious infections.
Merck Research Laboratories senior vice president, global clinical development head and chief medical officer Dr Roy Baynes said: “HABP and VABP are serious and life-threatening hospital-related pulmonary infections, especially in patients with severe underlying medical conditions.
“The results from the ASPECT-NP study demonstrate the potential role of ZERBAXA for the treatment of patients with HABP and VABP.”
Based on the results from the ASPECT-NP study, Merck plans to submit supplemental new drug applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for approving Zerbaxa to be used in the new indication.
Zerbaxa is an antibacterial combination product designed for intravenous infusion of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium.