Merck announces initiation of two Phase III trials for imipenem/cilastatin/relebactam combination for infections

Based in part on the results of its Phase II study, Merck is planning to initiate two pivotal Phase III clinical studies of relebactam with imipenem/cilastatin given as a fixed-dose combination. A study comparing imipenem/cilastatin/relebactam to colistimethate sodium in combination with imipenem/cilastatin for the treatment of imipenem-resistant bacterial infections, including those caused by P. aeruginosa and KPC-producing organisms, is currently recruiting patients. Infections evaluated in this study are hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. (www.ClinicalTrials.gov Identifier: NCT02452047).

A second Phase III study, which will initiate later this year, will compare treatment with the fixed-dose combination of imipenem/cilastatin/relebactam to piperacillin/tazobactam in patients with hospital-acquired and ventilator-associated bacterial pneumonia. (www.ClinicalTrials.gov Identifier: NCT02493764).