Status:
COMPLETED
A Study of the Safety and Effectiveness of Levofloxacin Compared With Ceftriaxone Sodium or Cefuroxime Axetil in the Treatment of Adults With Pneumonia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
This is a randomized, open-label, parallel group, multicenter study to determine the safety and effectiveness of levofloxacin (488 mg once daily by mouth or 500 mg administered intravenously once dail...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 1984
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 1995
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT00257049
Start Date
January 1 1984
End Date
January 1 1995
Last Update
June 10 2011
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