A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections
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: Bacterial Infections; Urinary Tract Infections; Bacteriuria; Urologic Diseases
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 the study is to compare the safety and effectiveness of oral levofloxacin (an
antibiotic) with that of oral lomefloxacin in the treatment of complicated urinary tract
infections in adults.
Clinical Details
Official title: A Multicenter, Randomized Study To Compare The Safety And Efficacy Of Oral Levofloxacin With That Of Lomefloxacin HCl In The Treatment Of Complicated Urinary Tract Infections In Adults
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical response, the resolution of signs and symptoms at post-therapy compared with those at start of study; Microbiological response, the eradication at post-therapy of infectious organism identified at start of study.
Secondary outcome: Overall clinical response, described as cured, improved, or failed; incidence of adverse events throughout the study; change in clinical laboratory tests and physical examinations from start of study to post-therapy.
Detailed description:
Levofloxacin is an antibacterial agent used for the treatment of a broad spectrum of acute
infections in adults. This is a randomized, open-label study of the safety and effectiveness
of levofloxacin compared with lomefloxacin in the treatment of adults with complicated
urinary tract infections. Patients in one group are treated with 250 mg of levofloxacin,
taken once daily for 7 to 10 days, and the other group is treated with 400 mg of
lomefloxacin, also an antibacterial agent, taken once daily for 14 days. Patients are
followed for 5 to 9 days after completion of treatment (post-therapy) to assess clinical
signs and symptoms of infection. Long-term follow up (4 to 6 weeks after the end of
treatment) of those patients who respond to therapy provides further evaluation of clinical
signs and symptoms. The primary assessments of effectiveness include the clinical response
(the resolution of signs and symptoms at post-therapy compared with those at the start of
study) and the microbiological response (the eradication at post-therapy of the infectious
organism identified at the start of study) An additional assessment of efficacy includes the
overall clinical response, which is described as cured, improved, or failed. Safety
assessments include the incidence of adverse events throughout the study, clinical laboratory
tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of
the study and post-therapy. The study hypothesis is that levofloxacin is at least as
effective therapeutically as lomefloxacin in the treatment of adults with complicated urinary
tract infections.
Levofloxacin tablets, an oral dose of 250 mg taken once daily for 7 to 10 days. Lomefloxacin
tablets, an oral dose of 400 mg taken once daily for 14 days.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of a urinary tract infection with complicating factors such as anatomical or
functional abnormalities
- Capable of taking medication by mouth
- Previous antibacterial therapy of less than 24 hours, or previous antibacterial
therapy of greater than 24 hours that did not eliminate or stabilize the infection
Exclusion Criteria:
- Patients having any medical condition that requires antimicrobial therapy to be given
intravenously or by hypodermic needle
- Complete obstruction of any part of the urinary tract
- Previous allergic or serious adverse reaction to similar antibiotics
- Inflammation of the prostate gland
- Pregnant or nursing females, or those lacking adequate contraception
Locations and Contacts
Additional Information
A study of the safety and effectiveness levofloxacin compared with lomefloxacin in the treatment of complicated urinary tract infections
Starting date: January 1993
Ending date: January 1995
Last updated: May 11, 2007
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