NCT01345929

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 558 (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 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Detailed description

Approximately 500 subjects will be enrolled into this study and randomized 1:1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug.

Conditions

• Complicated Urinary Tract Infection
• Pyelonephritis

Interventions

Type	Name	Description
DRUG	CXA-201	CXA-201 IV infusion (1500mg q8) for 7 days
DRUG	Levofloxacin	Levofloxacin IV infusion (750mg qd) for 7 days

Timeline

• Start date: 2011-06-20
• Primary completion: 2013-08-11
• Completion: 2013-09-04
• First posted: 2011-05-02
• Last updated: 2018-10-25
• Results posted: 2015-01-15

Locations

76 sites across 17 countries: United States, Brazil, Colombia, Estonia, Georgia, Germany, Hungary, Israel, Latvia, Mexico, Moldova, Romania, Russia, Serbia, Slovakia, South Africa, Thailand