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

NCT00042718 Phase 3 COMPLETED

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.

Details

Lead sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phase	Phase 3
Status	COMPLETED
Enrolment	659
Start date	2001-11
Completion	2003-08

Conditions

• Bronchitis
• Chronic Bronchitis

Interventions

• levofloxacin, azithromycin, amoxicillin/clavulanate

Primary outcomes

• Clinical response rates based on signs and symptoms at posttherapy visit.