Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections

Phase 2 Completed 122 enrolled Merck & Co., Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000 mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose adjustments for subjects with mild renal impairment are not necessary and subjects with more severe degrees of renal failure are excluded.

Timeline

Start: 2010-06-25
Primary completion: 2011-02-20
Completion: 2011-03-25

Publications

Lucasti C, Hershberger E, Miller B, Yankelev S, Steenbergen J, Friedland I, Solomkin J. Multicenter, double-blind, randomized, phase II trial to assess the safety and efficacy of ceftolozane-tazobactam plus metronidazole compared with meropenem in adult patients with complicated intra-abdominal infections. Antimicrob Agents Chemother. 2014 Sep;58(9):5350-7. doi: 10.1128/AAC.00049-14. Epub 2014 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftolozane-tazobactam	Small molecule	1.5 g	Intravenous
Comparator	Meropenem	Small molecule	1 g	Intravenous
Background	Metronidazole	Small molecule	500 mg	Intravenous

Indications

No indication recorded.