NCT01445678

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections

A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Efficacy and Safety of Intravenous CXA-201 With That of Meropenem in Complicated Intraabdominal Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections (cIAI).

Detailed description

Approximately, 500 subjects will be enrolled into this study, randomized 1:1 to receive CXA-201 and metronidazole or comparator (meropenem). Subject participation will require a minimum commitment of 38 days and a maximum of 45 days. An End of Treatment (EOT) visit will occur within 24 hours following the last dose of study drug administration/drug discontinuation. A Test of Cure (TOC)/Safety visit will be conducted 26 to 30 days following the first dose of study drug administration. A Last Follow-up (LFU) visit will be conducted 38 to 45 days after the first dose of study drug.

Conditions

• Complicated Intra-abdominal Infection

Interventions

Type	Name	Description
DRUG	CXA-201 and metronidazole	CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
DRUG	Meropenem	Meropenem IV infusion (1000mg q8h) for 4-14 days

Timeline

• Start date: 2011-12-23
• Primary completion: 2013-10-03
• Completion: 2013-10-15
• First posted: 2011-10-04
• Last updated: 2018-11-16
• Results posted: 2015-01-15

Locations

61 sites across 15 countries: United States, Argentina, Bulgaria, Chile, Croatia, Estonia, Germany, Hungary, Israel, Latvia, Lithuania, Moldova, Poland, Serbia, South Korea