PipEracillin Tazobactam versus mERoPENem for treatment of bloodstream infections caused by cephalosporin-resistant Enterobacteriaceae - a non-inferiority randomized controlled trial (PETERPEN)

Condition studied

Patients with bacteremia

Investigational medicinal product(s)

Eligibility

Primary endpoint

Treatment failure at day 7 from randomization. Treatment modifications before day 7 will be discouraged, but they will be allowed according to treating physicians’ discretion

Endpoint detail

•All-cause mortality 14,30,90days •Treatment failure 7,14,30days •Microbiological failure 7,14days •Relapse 30,90days •Clostridium difficile associated diarrhea till 90days •Development of either clinically or microbiologically documented infection other than Gram-negative bacteremia within 90days •Number of hospital re-admissions until day90, •Development of resistance •Carriage of carbapenemase-producing Enterobacteriaceae and non-CPE CRE in-hospital till day90 •Total in-hospital days within 30,90days •Total antibiotic days within 30,90days •Adverse events at 30days