Oral Sulopenem and Tebipenem for Complicated Urinary Tract Infection and Pyelonephritis in patients with Extended-Spectrum Beta-Lactamase (ESBL)-producing Gram Negative, Susceptible Bacteria

Abstract

ESBL-producing gram negative Enterobacteria is becoming more prevalent, and carbapenems play a key role in combating against ESBL for complicated urinary tract infections (cUTI). However, carbapenems are only available intravenously in the U.S. FDA is currently reviewing the newly developed oral carbapenems (sulopenem and tebipenem) and have requested additional clinical trial information before granting approval for cUTI. Currently available phase 3 clinical trials for tebipenem and sulopenem are reviewed