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