A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.

• ClinicalTrials.gov Identifier: NCT00210886
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: June 10, 2011
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Urinary Tract Infections; Pyelonephritis	Drug: levofloxacin	Phase 3

Detailed Description:

Levofloxacin has been approved in both its oral and intravenous forms to treat a large number of infections caused by bacteria. Levofloxacin and other members of a class of antibiotics known as fluoroquinolones have been used successfully to treat urinary and kidney infections. This study will compare the effectiveness and safety of levofloxacin given for 5 days to that of another fluoroquinolone, ciprofloxacin, given for 10 days in treating complicated urinary tract infection or acute pyelonephritis (kidney infection). A shorter course of antibiotics may help patients take all of their medication, which is critically important for curing the infection. A shorter course may also help prevent the development of bacteria that cannot be killed by antibiotics. Patients will take 750 milligrams of levofloxacin intravenously and/or by mouth once daily for 5 days or 400 milligrams of ciprofloxacin intravenously and/or 500 milligrams of ciprofloxacin by mouth twice daily for 10 days. To prevent the study doctor, study staff and patients from knowing which study drug they are taking, all study drug will manufactured to look the same and patients on the 5-day regimen will be given placebo for the last 5 days of their participation in the study. The intravenous infusion bags will be covered so that the solution cannot be seen. The objective of the study is to demonstrate that 5 days of levofloxacin once daily is at least as effective as 10 days of ciprofloxacin twice daily in treating complicated urinary tract infection or acute pyelonephritis. Patients will take 750 milligrams of levofloxacin intravenously and/or by mouth once daily for 5 days or 400 milligrams of ciprofloxacin intravenously and/or 500 milligrams of ciprofloxacin by mouth twice daily for 10 days.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-blind, Randomized Study to Compare the Efficacy and Safety of Levofloxacin 750 mg Once Daily for Five Days Versus Ciprofloxacin Twice Daily for Ten Days in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis.
• Study Start Date: October 2004
• Actual Study Completion Date: April 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Combination of clinical success and microbiologic eradication (known as therapeutic response) at post-therapy visit.

Secondary Outcome Measures :

1. By patient and pathogen microbiologic and clinical responses at the post-therapy and post-study visits.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Positive dipstick test for leukocyte esterase AND/OR at least 5 white blood cells per centrifuged urine sediment AND/OR at least 10 white blood cells per microliter of uncentrifuged urine
• outpatient or inpatient (in hospital, nursing home, or other extended-care facility)
• clinical diagnosis of either complicated urinary tract infection or acute pyelonephritis.

Exclusion Criteria:

• Allergy or serious adverse reaction to levofloxacin, ciprofloxacin, or other fluoroquinolone
• urinary tract surgery or lithotripsy (treatment for kidney stones) within 7 days before study entry
• a second coexisting bacterial infection that requires systemic antibiotics
• need for a second antibiotic to treat the urinary tract infection
• obstruction of the urinary tract
• prostate infection.

Contacts and Locations

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

• Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

Levofloxacin Versus Ciprofloxacin in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis 

Publications of 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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• ClinicalTrials.gov Identifier: NCT00210886 History of Changes
• Other Study ID Numbers: CR004705
• First Posted: September 21, 2005
• Last Update Posted: June 10, 2011
• Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

complicated urinary tract infection; urinary tract infection; acute pyelonephritis; pyelonephritis; kidney infection; bladder infection

Additional relevant MeSH terms:

Infection; Communicable Diseases; Urinary Tract Infections; Pyelonephritis; Urologic Diseases; Nephritis, Interstitial; Nephritis; Kidney Diseases; Pyelitis; Levofloxacin; Ofloxacin; Ciprofloxacin; Anti-Infective Agents, Urinary; Anti-Infective Agents; Renal Agents; Anti-Bacterial Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors