Overview

A Study of the Effectiveness and Safety of High Dose, Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis.

Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and effectiveness of four oral antibiotic treatment regimens for bacterial infections in patients with chronic bronchitis. The study goals are to demonstrate that 1) levofloxacin 750 mg once daily for three days is no worse than azithromycin 250 mg twice a day for one day and then 250 mg once a day for four more days, and 2) levofloxacin 750 mg once daily for five days is no worse than amoxicillin/ clavulanate (875/125 mg) twice daily for 10 days.
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:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Azithromycin
Clavulanic Acid
Clavulanic Acids
Levofloxacin
Ofloxacin
Criteria
Inclusion Criteria:

- History of chronic bronchitis

- Diagnosis of Type-1 or Type-2 acute bacterial exacerbation (worsening) of chronic
bronchitis (ABECB) with at least the presence of both increased sputum production and
increased sputum purulence with evidence of inflammatory cells

- If female, must be postmenopausal, surgically sterile, or practicing an effective
method of birth control

Exclusion Criteria:

- Diagnosis of bronchial asthma

- Allergy or serious adverse reaction to any of the study medications or other
antibiotics

- Failed treatment for pneumonia or acute bacterial exacerbation (worsening) of chronic
bronchitis ABECB in three months prior to enrollment in the study with any of the
study medications or other antibiotics

- Can not tolerate medication taken by mouth