Avelox® for Treatment of Elderly Patients With Community Acquired Pneumonia

Inclusion Criteria:

• Presence of radiological evidence of a new or progressive infiltrate(s) consistent with bacterial pneumonia and at least 2 of the following:
• Productive cough with purulent or mucopurulent sputum/tracheobronchial secretions or change in the character of sputum (increased volume or purulence)
• Dyspnea or tachypnea
• Rigors or chills
• Pleuritic chest pain
• Auscultatory findings on pulmonary examination of rales/crackles and/or evidence of pulmonary consolidation
• Fever or hypothermia
• White blood cell count >/= 10000/mm3 or >/= 15% immature neutrophils, regardless of the peripheral WBC count, or leukopenia with total WBC count < 4500/mm3

Exclusion Criteria:

• Known hypersensitivity to fluoroquinolones
• Presence of end-organ damage or shock with need for vasopressors for > 4 hours at the time of study entry
• Need for mechanical ventilation at study entry
• Implanted cardiac defibrillator.
• Significant bradycardia with heart rate < 50 beats/minute.
• Hospitalized for > 48 hours before developing pneumonia.
• Systemic antibacterial therapy for more than 24 hours within 7 days of enrollment unless the patient was deemed a treatment failure after receiving greater than 72 hours of a non-fluoroquinolone antibiotic.
• Co-existent disease considered likely to affect the outcome of the study (e.g. active lung cancer, connective tissue disease affecting the lungs, bronchiectasis).
• Mechanical endobronchial obstruction (e.g. endobronchial tumor).
• Known or suspected active tuberculosis or endemic fungal infection.
• Neutropenia (neutrophil count < 1000/Microliter).
• Chronic treatment (equal or longer than 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent).
• Patient with known HIV infection and a CD4 count < 200/mm3 .
• Known severe hepatic insufficiency .
• Renal impairment with a baseline measured or calculated serum creatinine clearance < 20 mL/min. If a recent value for a 24 hour creatinine clearance is not available then the creatinine clearance should be calculated using the Cockcroft-Gault formula .
• Known prolongation of the QT interval or use of Class IA or Class III antiarrhythmics (e.g., quinidine, procainamide, amiodarone, sotalol).
• Uncorrected hypokalemia.
• Previous history of tendinopathy with quinolones.
• Previously entered in this study.
• Participated in any clinical investigational drug study within 4 weeks of screening.
• Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment.
• Patients with a history of a hypersensitivity reaction to multivitamin infusion (MVI) or pre-existing hypervitaminosis.