avelox for treatment of elderly patients with community acquired pneumonia

Conditions: Pneumonia

Summary: 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.

Keywords: community acquired pneumonia pneumonia, cap