1959. Ceftriaxone-Sulbactam-EDTA (CSE) vs. Meropenem (MR) in PLEA (a Phase 3 Randomized Double-Blind Trial): Outcomes in Patients Infected With Ceftriaxone Non-Susceptible Extended-Spectrum β-Lactamase and Multi-Drug-resistant Pathogens at Baseline

摘要

BackgroundCSE, a novel combination of Ceftriaxone, Sulbactam and Disodium EDTA (Class 1 Antibiotic Resistance Breaker), is being developed for the treatment of patients with serious Gram-negative infections and has completed a Phase-3 clinical trial () for treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). It restores and enhances the in vitro activity of Ceftriaxone against various β-lactamases (BLs), including enzyme families that belong to Ambler class A (TEM, SHV, CTX-M), class B (NDM, VIM, IMP), class C (some variants of AmpC), and class D {OXA extended spectrum BLs (ESBLs)}. This analysis was performed to assess the clinical and microbiological outcomes in patients infected with Ceftriaxone non-susceptible (C-NS), MDR and ESBL-producing Gram-negative pathogens at baseline.