Pneumonia Clinical Trial
Official title:
A Multicenter, Active-Controlled, Randomized Study To Evaluate The Safety And Efficacy Of Levofloxacin Versus Ceftriaxone Sodium Or Cefuroxime Axetil In The Treatment Of Community-Acquired Pneumonia In Adults
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.
Status | Completed |
Enrollment | 604 |
Est. completion date | January 1995 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | PriCara, Unit of Ortho-McNeil, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response rate (reduction in signs and symptoms, improvement in x-ray findings) at post-therapy (5 - 7 days after the last dose of study drug). | |||
Secondary | Rate of elimination of disease-causing bacteria, by patient, and by type of bacteria; incidence of adverse events; changes in physical examination and laboratory tests after treatment with study drug |
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