A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Cefuroxime Axetil in the Treatment of Adults With Persistent Bronchitis Experiencing Rapid Onset of Severe Worsening of Symptoms Caused by Bacteria

• Status: Completed
• Trial end date: 1994-05-01
• 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 cefuroxime axetil, another antibiotic, in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.

• Phase: 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: Cefuroxime; Cefuroxime axetil; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Diagnosis of chronic obstructive lung disease (chronic bronchitis and/or emphysema) with rapid onset of worsening of symptoms caused by bacterial infection

• recent increase in cough

• change in type or amount of sputum (the mucus produced on coughing)

• findings during the physical examination of clinical signs and symptoms of chronic obstructive lung disease

• 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 patient has a requirement for a second 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 drugs

• previous allergic or serious adverse reaction to antibiotics similar to the study drugs

• diagnosis of pneumonia determined by x-ray at the start of the trial

• has cystic fibrosis, seizure disorders, kidney disease, or an unstable psychiatric condition.