- Subjects must require hospitalization and intravenous therapy.
- Subjects must have a Fine pneumonia score > 70 (Fine Class > II).
- Subjects must have a medical history and clinical and radiological findings
consistent with a community-acquired bronchopneumonia or lobar pneumonia. The
following criteria must be met:
- new infiltrate(s) on chest X-ray; AND
- at least two of the CAP signs or symptoms.
- Treatment with any systemic antibiotic for 24 hours or longer within 72 hours of the
baseline visit, or treatment for more than 7 days within 15 days.
- Specific systemic diseases or other medical conditions that would interfere with the
evaluation of the therapeutic response or safety of the study drug, including:
- Known acquired immunodeficiency syndrome (AIDS) or suspected Pneumocystis
- Cavitary lung disease by chest X-ray;
- Primary lung cancer or other malignancy metastatic to the lung;
- Aspiration pneumonia;
- Known or suspected tuberculosis;
- Neoplastic disease;
- Cystic fibrosis;
- A history of any form of epilepsy or seizure;
- Bronchiectasis, bronchial obstruction or history of post-obstructive pneumonia
(this does not exclude patients with chronic obstructive pulmonary disease);
- Significant gastrointestinal or other conditions which may affect study drug
- Significant cardiovascular disorders.
- Immunosuppressive therapy, defined as chronic treatment with known immunosuppressant
- Impaired hepatic function, as shown by, but not limited to, AST, (SGOT), or ALT
(SGPT) greater than three times the laboratory upper limit of normal, or total
bilirubin greater than two times the upper limit of normal.
- Subjects already hospitalized or who resided in a long-term-care facility for greater
than 14 days before the onset of symptoms.