Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Bronchitis
Bronchitis, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 exp...
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 cef...
Eligibility Criteria
Inclusion
- Diagnosis of chronic bronchitis with a rapid onset of worsening of symptoms caused by bacteria
- history of chronic obstructive lung disease (chronic bronchitis and/or emphysema)
- recent increase in cough
- change in type of sputum (the mucus produced on coughing) and/or an increase in the production of sputum
- received previous antibiotic treatment if the previous treatment lasted for 24 hours or less, or if the previous treatment lasted longer than 24 hours but there was no improvement or stabilization of the disease.
Exclusion
- Illness requiring antibiotic treatment by injection into a vein, beneath the skin, or into a muscle, or has a requirement of an antibiotic medication taken orally in addition to the study drug
- infection due to bacteria known (prior to the start of the study) to be resistant to the study drug
- previous allergic or serious adverse reaction to similar antibiotics
- diagnosis of pneumonia, determined by a chest x-ray at the start of the trial
- has cystic fibrosis, seizure disorders, kidney disease, or an unstable psychiatric condition.
Key Trial Info
Start Date :
June 1 1931
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1994
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00257140
Start Date
June 1 1931
End Date
July 1 1994
Last Update
June 10 2011
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