At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 558 enrolled
Drug / intervention
CXA-201 +1 moredrug
Likely dose
CXA-201 1500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted May 2, 2011·Updated Oct 25, 2018
In Brief
A Phase 3 clinical trial evaluating CXA-201 and Levofloxacin for Complicated Urinary Tract Infection and Pyelonephritis. Completed, enrolled 558 participants across 76 sites in 17 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Colombia, Estonia, Georgia, Germany, Hungary, Israel, Latvia, Mexico, Moldova, Romania, Russia, Serbia, Slovakia, South Africa, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJun 2011
Primary CompletionAug 2013
Study CompletionSep 2013
TodayJul 2026
First PostedMay 2, 2011
Enrollment StartJun 20, 2011
Primary CompletionAug 11, 2013
Study CompletionSep 4, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.2 years ago
Interventions
CXA-201drug
CXA-201 IV infusion (1500mg q8) for 7 days
Levofloxacindrug
Levofloxacin IV infusion (750mg qd) for 7 days