Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

This study was to assess the safety of sequential intravenous (IV)/oral (PO) moxifloxacin (Avelox®) compared with sequential IV/PO levofloxacin (Levaquin®) in the treatment of elderly subjects (aged \&#8805; 65 years) with community-acquired pneumonia (CAP) who required initial IV therapy. This study also included an assessment of the clinical and bacteriologic effectiveness of both drugs.


Eligibility Criteria:
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.