CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria

Summary

The purpose of this study is to evaluate the effects of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) compared to Meropenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis caused by β-lactamase producing gram-negative bacteria

Timeline

Start

2014-01-11

Primary completion

2017-05-08

Completion

2017-05-08

Outcome

Met primary endpoint

paper Noninferiority of CSE to meropenem was demonstrated for both the US Food and Drug Administration defined co-primary endpoints PMID 31433059 ↗

paper symptomatic resolution at test-of-cure: 71/74 (95.9%) patients vs 62/69 (89.9%) [treatment difference, 6%; 95% CI, -2.6% to 16%] PMID 31433059 ↗

paper both symptomatic resolution and microbiological eradication at test-of-cure: 70/74 (94.6%) vs 60/69 (87.0%) (treatment difference, 7.6%; 95% CI, -2.0% to 18.4%). PMID 31433059 ↗

Publications

• Results Mir MDA, Chaudhary S, Payasi A, Sood R, Mavuduru RS, Shameem M. 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. Open Forum Infect Dis. 2019 Oct 1;6(10):ofz373. doi: 10.1093/ofid/ofz373.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftriaxone	Other / unclassified	1000 mg	Intravenous
Subject	Edetate Calcium Disodium	Unknown	37 mg	Intravenous
Comparator	Meropenem	Small molecule	1000 mg	Intravenous
Subject	Sulbactam	Small molecule	500 mg	Intravenous

Indications