Sulopenem followed by oral sulopenem etzadroxil or probenecid was not noninferior to ertapenem for complicated UTIs

A recent study found that the administration of sulopenem intravenously followed by oral administration is an effective treatment for complicated urinary tract infections (cUTIs). These formulations were found not to be inferior to ertapenem followed by oral step-down therapy for the treatment of cUTIs. The results of this study were published in the journal, Clinical Infectious Diseases.

This phase 3 trial randomized 1392 hospitalized adults with symptoms of cUTIs to 5 days of IV sulopenem followed by oral sulopenem etzadroxil/probenecid or 5 days of IV ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate, depending on uropathogen susceptibility. The primary end point was overall combined clinical and microbiologic response at the test-of-cure visit (day 21).

Sulopenem's noninferiority to the comparator regimen was not demonstrated for the primary end point. The difference was due to a lower rate of asymptomatic bacteriuria in the ertapenem-treated patients who switched to ciprofloxacin. There was no substantial difference in overall response at any other time point.

Thus, sulopenem followed by oral sulopenem-etzadroxil/probenecid is not noninferior to ertapenem followed by oral step-down therapy for the treatment of cUTIs.