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

• Status: Completed
• Trial end date: 1994-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Cefaclor; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.