drugset / Trial / NCT00210886
A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.
Phase 3
Completed
1109 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the effectiveness and safety of two antibiotics in the treatment of complicated urinary tract infection or acute pyelonephritis (kidney infection). A 5-day course of 750 milligrams of levofloxacin given intravenously and/or by mouth once daily will be compared to a 10-day course of 400 milligrams of ciprofloxacin given intravenously and/or 500 milligrams of ciprofloxacin given by mouth twice daily.
Timeline
- Start
- 2004-10
- Primary completion
- —
- Completion
- 2006-04
Publications
- Results Peterson J, Kaul S, Khashab M, Fisher AC, Kahn JB. A double-blind, randomized comparison of levofloxacin 750 mg once-daily for five days with ciprofloxacin 400/500 mg twice-daily for 10 days for the treatment of complicated urinary tract infections and acute pyelonephritis. Urology. 2008 Jan;71(1):17-22. doi: 10.1016/j.urology.2007.09.002.
- Results Klausner HA, Brown P, Peterson J, Kaul S, Khashab M, Fisher AC, Kahn JB. A trial of levofloxacin 750 mg once daily for 5 days versus ciprofloxacin 400 mg and/or 500 mg twice daily for 10 days in the treatment of acute pyelonephritis. Curr Med Res Opin. 2007 Nov;23(11):2637-45. doi: 10.1185/030079907x233340.
- Results Peterson J, Kaul S, Khashab M, Fisher A, Kahn JB. Identification and pretherapy susceptibility of pathogens in patients with complicated urinary tract infection or acute pyelonephritis enrolled in a clinical study in the United States from November 2004 through April 2006. Clin Ther. 2007 Oct;29(10):2215-21. doi: 10.1016/j.clinthera.2007.10.008.
- Mospan GA, Wargo KA. 5-Day versus 10-Day Course of Fluoroquinolones in Outpatient Males with a Urinary Tract Infection (UTI). J Am Board Fam Med. 2016 Nov 12;29(6):654-662. doi: 10.3122/jabfm.2016.06.160065.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levofloxacin | Small molecule | 750 mg | Intravenous |