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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.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Tract Infections; Bacterial 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 & 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Last updated: June 8, 2011

Page last updated: August 23, 2015

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