A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pyelonephritis; Urinary Tract Infections
Intervention: levofloxacin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Combination of clinical success and microbiologic eradication (known as therapeutic response) at post-therapy visit.
Secondary outcome: By patient and pathogen microbiologic and clinical responses at the post-therapy and post-study visits.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Levofloxacin Versus Ciprofloxacin in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis
Starting date: October 2004
Ending date: April 2006
Last updated: March 31, 2008
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