This study compared the safety and efficacy of Avelox® vs. Levaquin® for the treatment of
Community Acquired Pneumonia (CAP) in patients >= 65 years of age.
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.
San Juan 00921-3201, Puerto Rico
Tucson, Arizona 85723, United States
Fullerton, California 92835-3800, United States
Madera, California 93637, United States
La Jolla, California 92093, United States
Brea, California 92821-3075, United States
Bridgeport, Connecticut 06610, United States
Farmington, Connecticut 06030, United States
Brandon, Florida 33511, United States
Orlando, Florida 32806-2093, United States
Fort Gordon, Georgia 30905, United States
Marietta, Georgia 30060, United States
Blue Ridge, Georgia 30513, United States
Columbus, Georgia 31902, United States
Austell, Georgia 30106-8116, United States
Coeur d'Alene, Idaho 83814-4487, United States
Springfield, Illinois 62703, United States
Indianapolis, Indiana 46202-2879, United States
New Orleans, Louisiana 70112, United States
Shreveport, Louisiana 71130-4228, United States
New Orleans, Louisiana 70127-3154, United States
Cumberland, Maryland 21502, United States
Royal Oak, Michigan 48073-6769, United States
Kalamazoo, Michigan 49048-1666, United States
Duluth, Minnesota 55805-1984, United States
Anaconda, Montana 59711-2718, United States
Holmdel, New Jersey 07733, United States
Newark, New Jersey 07712-2027, United States
New York, New York 10029, United States
Albany, New York 12208-3473, United States
Elizabeth City, North Carolina 27909, United States
Chapel Hill, North Carolina 27599-7065, United States
Winston-Salem, North Carolina 27103, United States
Dayton, Ohio 45428, United States
Columbus, Ohio 43214-3998, United States
Akron, Ohio 44304, United States
Tulsa, Oklahoma 74136-1902, United States
Beaver, Pennsylvania 15009, United States
Allentown, Pennsylvania 18102, United States
Hershey, Pennsylvania 17033-0850, United States
Summerville, South Carolina 29485, United States
Jackson, Tennessee 38301-3855, United States
San Antonio, Texas 78217-0156, United States
San Antonio, Texas 78284-5799, United States
San Antonio, Texas 78229, United States
Salt Lake City, Utah 84102, United States
Lynchburg, Virginia 24501-1109, United States
