Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258089
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2005-11-22
Brief Title:
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Study To Compare The Safety And Efficacy Of Oral Levofloxacin With That Of Ciprofloxacin HCl In The Treatment Of Complicated Urinary Tract Infections In Adults
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare the safety and effectiveness of oral levofloxacin an antibiotic with that of oral ciprofloxacin in the treatment of complicated urinary tract infections in adults
Detailed Description:
Levofloxacin is an antibacterial agent used for the treatment of a many types of acute infections in adults This is a randomized double-blind study of the safety and effectiveness of levofloxacin compared with ciprofloxacin in the treatment of adults with a complicated urinary tract infection Complicated urinary tract infections include those associated with fever chills kidney involvement or anatomic and functional abnormalities of the bladder Patients in one group are treated with 250 mg of levofloxacin taken once daily for 10 days and the other group is treated with 500 mg of ciprofloxacin also an antibacterial agent taken twice daily for 10 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 microbiological response the eradication at post-therapy of the infectious organism identified at the start of the study and the clinical response the resolution of signs and symptoms at post-therapy compared with those at the start of the 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 and as well tolerated as ciprofloxacin in the treatment of adults with complicated urinary tract infections Two levofloxacin 125 mg tablets taken orally once daily and two placebo tablets taken once daily 12 hours later for 10 days or one ciprofloxacin 500 mg tablet and one placebo tablet taken orally twice daily for 10 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None