NCT00210886

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,109

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

First QC Date

September 13, 2005

Last Update Submit

June 8, 2011

Conditions

Urinary Tract InfectionsPyelonephritis

Keywords

complicated urinary tract infectionurinary tract infectionacute pyelonephritispyelonephritiskidney infectionbladder infection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

levofloxacinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 18242357RESULT

  • 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.

    PMID: 17880755RESULT

  • 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.

    PMID: 18042477RESULT

  • 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.

    PMID: 28076247DERIVED

Related Links

MeSH Terms

Conditions

Urinary Tract InfectionsPyelonephritisCystitis

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephritis, InterstitialNephritisKidney DiseasesPyelitisUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2004

Study Completion

April 1, 2006

Last Updated

June 10, 2011

Record last verified: 2010-04