At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 804 enrolled
Drug / intervention
Moxifloxacin (Avelox, BAY12-8039) +1 moredrug
Likely dose
Moxifloxacin (Avelox, BAY12-8039) 400mgfrom 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 Prospective, Randomized, Double-dummy, Double-blind, Multicenter Trial Comparing the Safety and Efficacy of Intravenous Moxifloxacin 400 mg IV QD 24 Hours to That of Ertapenem 1.0 g IV QD 24 Hours for 5 to 14 Days for the Treatment of Subjects With Complicated Intra-abdominal Infections (PROMISE Study)
In Brief
A Phase 3 clinical trial evaluating Moxifloxacin (Avelox, BAY12-8039) and Ertapenem intravenous for Infection. Completed, enrolled 804 participants across 52 sites in 14 countries.
Detailed Summary
A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection
CountriesArgentina, Belgium, Bulgaria, Estonia, France, Germany, Greece, Israel, Latvia, Lithuania, Romania, Russia, South Africa, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedJun 2007
Primary CompletionFeb 2009
TodayJul 2026
First PostedJun 27, 2007
Enrollment StartJul 1, 2006
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.0 years ago
Interventions
Moxifloxacin (Avelox, BAY12-8039)drug
Moxifloxacin, 400mg, administered intravenously once daily
Ertapenem intravenousdrug
Active treatment: Ertapenem 1.0g, administered intravenously once daily