CSE (Ceftriaxone+ Sulbactam+ Disodium EDTA) Versus Meropenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: PLEA, a Double-Blind, Randomized Noninferiority Trial.

ABSTRACT:

Background

CSE is a novel combination of ceftriaxone, sulbactam and disodium EDTA with activity against multidrug resistant gram-negative pathogens.

Methods

Adult patients aged ≥18 years with a diagnosis of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), were randomized 1:1 to receive either intravenous CSE (1000mg ceftriaxone/500mg sulbactam/37mg disodium EDTA) every 12h or intravenous meropenem (1000mg) every 8h for up to 14 days. The primary objective was to show the noninferiority of CSE to meropenem at the test-of-cure visit (8-12 days after the end of therapy), with a noninferiority margin of 10 percent.

Results

Of 230 randomized patients, 74/143 and 69/143 were treated with CSE and meropenem respectively. Of these, 98% were cef

SUBMITTER: Mir MDA 

PROVIDER: S-EPMC6767967 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature