Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042718
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2002-08-05
Brief Title:
A Study of the Effectiveness and Safety of High Dose Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation Worsening of Chronic Bronchitis
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-04
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 this study is to evaluate the safety and effectiveness of four oral antibiotic treatment regimens for bacterial infections in patients with chronic bronchitis The study goals are to demonstrate that 1 levofloxacin 750 mg once daily for three days is no worse than azithromycin 250 mg twice a day for one day and then 250 mg once a day for four more days and 2 levofloxacin 750 mg once daily for five days is no worse than amoxicillin clavulanate 875125 mg twice daily for 10 days
Detailed Description:
This is a randomized double-blind multicenter treatment study to evaluate the efficacy and safety of high-dose short-course oral levofloxacin treatment versus treatment with other oral antibiotics in acute bacterial exacerbation of chronic bronchitis ABECB This study evaluates the use of high-dose 750 milligrams and short-course 3 or 5 days levofloxacin compared with conventional doses and schedules of other effective antibiotics for controlling acute bacterial infections in patients with chronic bronchitis The study will divide the 700 patients into two groups--one group with less severe uncomplicated chronic bronchitis and one with more severe complicated chronic bronchitis Patients with uncomplicated disease will receive levofloxacin 750 mg once daily for 3 days or azithromycin 250 mg twice a day for 1 day and then 250 mg once a day for 4 more days Patients with complicated disease will receive levofloxacin 750 mg once daily for 5 days or amoxicillin clavulanate 875125 mg twice daily for 10 days All patients will take study medication orally Effectiveness will be measured by comparing the patients signs and symptoms present at the Test-of-Cure Visits study days 13 - 22 with those observed at the Study Entry Visit Safety will be evaluated throughout the study on the basis of the occurrence and severity of unexpected and undesirable events as well as by laboratory tests and physical examinations The hypothesis of the study is that a shorter course 3 days of 750 mg levofloxacin will be at least as effective and well tolerated as azithromycin for 5 days for uncomplicated ABECB and that 750 mg of levofloxacin for 5 days will be at least as effective and well tolerated as amoxicillin clavulanate for 10 days for curing complicated ABECB cases
Uncomplicated ABECB Oral doses of levofloxacin 750 mg once daily for 3 days or azithromycin 250 mg twice daily on day 1 then 250 mg once daily on days 2 - 5 Complicated ABECB Oral doses of levofloxacin 750 mg once daily for 5 days or amoxicillinclavulante 875125 mg once daily for 10 days
Uncomplicated ABECB Oral doses of levofloxacin 750 mg once daily for 3 days or azithromycin 250 mg twice daily on day 1 then 250 mg once daily on days 2 - 5 Complicated ABECB Oral doses of levofloxacin 750 mg once daily for 5 days or amoxicillinclavulante 875125 mg once 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