A Study of the Safety and Effectiveness of Levofloxacin Compared With Ceftriaxone Sodium or Cefuroxime Axetil in the Treatment of Adults With Pneumonia

• Status: Completed
• Trial end date: 1995-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is evaluation of the safety and effectiveness of levofloxacin, an antibiotic, compared with ceftriaxone sodium or cefuroxime axetil in the treatment of adults with pneumonia.

• 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: Ceftriaxone; Cefuroxime; Cefuroxime axetil; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Diagnosis of pneumonia based upon clinical signs and symptoms of a lower respiratory tract infection including at least 2 of the following: fever, cough, greenish-yellow mucus produced on coughing, chest pain, shortness of breath, or evidence of decreased lung function during the physical examination

• has chest x-ray findings consistent with acute pneumonia

• previously received antibiotics for pneumonia if the duration of therapy was <= 24 hours, or if greater than 24 hours, but without improvement or stabilization with that therapy.

Exclusion Criteria:

• Previous allergic or serious adverse reaction to any antibiotic similar to those used in this study or to penicillin

• collection of pus in the cavity between the lung and the membrane that surrounds it

• has cystic fibrosis

• has a lung infection due to fungus, bacteria, or virus known prior to the start of the study to be resistant to any of the study drugs

• has severe kidney failure, decrease in white blood cell count, seizure disorder, or an unstable psychiatric condition.