A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of two antibiotic regimens in the treatment of community-acquired pneumonia in non-hospitalized adult patients. A 5-day course of 750 milligrams of levofloxacin given once daily will be compared to a 10-day course 500 milligrams of levofloxacin given once daily.

• 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: Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Diagnosis of community-acquired pneumonia as follows: clinical signs and symptoms of a lower respiratory tract infection and chest-x-ray findings consistent with pneumonia within 24 hours before entry into the study

• At least one of the following: abnormal temperature (high or low) or abnormal white blood cell count

• Previous antibiotic treatment <= 24 hours or, if the duration of treatment was >= 72 hours and that therapy failed based on at least 2 of the following: fever within 12 hours of entry into the study, chest x-ray findings have worsened compared to the initial chest-x-ray, white blood cell count is significantly increased, respiratory rate higher than at the start of treatment and >= 20 breaths per minute or need for supplemental oxygen if not previously needed

• Patients whose infection is acquired in the community or, if in a nursing home, who had been living there < 14 days

• Fine Class (rating scale used to assess patients' overall condition which includes information such as age, gender, other diseases, physical examination and laboratory findings) score <= 130 upon admission (patients with Fine Class scores > 70 but < = 130 must initially be hospitalized

• Patients with scores of <= 70 may be treated as outpatients or hospitalized at the discretion of the investigator)

Exclusion Criteria:

• Pneumonia known or suspected to be due to a bacteria resistant to levofloxacin

• Previous allergic or serious reaction to or failed therapy with levofloxacin or similar drugs

• Life expectancy < 72 hours

• Hospitalized within 2 weeks before entry in the study or within 1 month before entry in the study if treated with antibiotics

• Pneumonia acquired in a hospital

• Cystic fibrosis or other lung disorders

• Receiving chronic steroid treatment

• Received assistance from a machine to breathe within the previous month