Phase III trial initiated for imipenem/cilastatin/relebactam to treat intra-abdominal infections- Merck

A Phase III, randomised, double-blind, active comparator-controlled clinical trial to estimate the efficacy and safety of imipenem/cilastatin/relebactam versus colistimethate sodium + imipenem/cilastatin in subjects with imipenem-resistant bacterial infection is currently recruiting participants with intra abdominal infections. Anticipated enrolment is 64 patients. This is a study supported by Merck Inc.

Comment: The FDA has designated relebactam (previously known as MK-7655), the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. The QIDP and Fast Track designations apply to intravenous use of relebactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Imipenem + cilastatin is marketed as Primaxin and has been available for many years and is generic.