Imipenem/relebactam/cilastatin (Merck) was found to be noninferior to piperacillin/tazobactam in adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), according to data from the RESTORE-IMI 2 study.
The phase 3 trial included 537 patients who required treatment with intravenous antibiotic therapy for HABP or VABP. Patients were randomized to receive imipenem/relebactam/cilastatin or piperacillin/tazobactam, both as a fixed-dose combination every 6 hours for a minimum of 7 days and up to 14 days; at study entry, open label linezolid was also administered every 12 hours for up to 14 days. The primary end point of the study was the percentage of patients surviving at Day 28; a favorable clinical response at the early follow-up visit was designated as a secondary outcome measure.
Results showed that the trial met both the primary and secondary end points, demonstrating the statistical noninferiority of imipenem/relebactam/cilastatin compared with piperacillin/tazobactam in the modified intent-to-treat population. Additional data from the study will be presented at a future scientific congress, according to the Company.
“Additional treatment options are needed for critically ill patients with respiratory infections,” said Dr Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories. “By evaluating [imipenem/relebactam/cilastatin] in this patient population, we have generated robust clinical evidence for its potential use in patients with hospital-acquired and ventilator-associated bacterial pneumonia. We look forward to sharing these data with the regulatory agencies.”
Imipenem/relebactam/cilastatin (Recarbrio) is currently approved for the treatment of adult patients aged 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis, and for the treatment of complicated intra-abdominal infections (cIAI). Recarbrio is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a new beta-lactamase inhibitor. It should only be used to treat or prevent infections in patients who have limited or no alternative treatment options.
For more information visit merck.com.