NCT01147640

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

A Multicenter, Double-Blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA 101/ Tazobactam and Metronidazole With That of Meropenem in Complicated Intraabdominal Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complicated Intra-abdominal Infection

Interventions

Type	Name	Description
DRUG	CXA-101/ tazobactam and metronidazole	CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
DRUG	meropenem plus saline placebo	meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion

Timeline

• Start date: 2010-06-25
• Primary completion: 2011-02-20
• Completion: 2011-03-25
• First posted: 2010-06-22
• Last updated: 2018-10-25
• Results posted: 2015-01-16

Locations

33 sites across 5 countries: United States, Argentina, Georgia, Russia, Serbia