Overview

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.