Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257140
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-11-18
Brief Title:
A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Active-Controlled Randomized Study to Evaluate the Safety and Efficacy of Oral Levofloxacin Versus Cefaclor in the Treatment of Acute Bacterial Exacerbation of Chronic Bronchitis in Adults
Status:
COMPLETED
Status Verified Date:
2011-01
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 levofloxacin an antibiotic compared with cefaclor another antibiotic in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria
Detailed Description:
This is a randomized open-label parallel group multicenter study to determine the effectiveness and safety of 488 mg of levofloxacin once daily by mouth for 5 - 7 days compared with 250 mg of cefaclor every 8 hours for 7 - 10 days in adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacterial infection The study consists of 3 visits one visit for screening and enrollment and 2 visits for assessment of safety and effectiveness one visit on Days 3 - 5 of the study and one visit post-therapy 5 - 7 days after the last dose of the study drug The total duration of patient participation in the study is approximately 2 weeks Levofloxacin and cefaclor are antibacterial agents used for the treatment of many types of infections including infections with a rapid onset and brief duration caused by bacteria The primary assessment of effectiveness in this study is the microbiologic response to treatment the rate of elimination of disease-causing bacteria by patient and by type of bacteria 5 - 7 days after the last dose of study drug Safety evaluations incidence of adverse events physical examination laboratory tests are performed throughout the study The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with cefaclor in adult patients with chronic bronchitis experiencing sudden worsening of symptoms caused by bacterial infection Levofloxacin 488 mg by mouth once daily for 5 - 7 days or cefaclor 250 mg by mouth every 8 hours for 7 - 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