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 ≥ 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.
Minimum age: 65 Years.
Maximum age: N/A.
- 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
- 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
- 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
- Patients with a history of a hypersensitivity reaction to multivitamin infusion (MVI)
or pre-existing hypervitaminosis.
San Juan 00921-3201, Puerto Rico
Mobile, Alabama 36608-1798, United States
Tucson, Arizona 85723, United States
Tucson, Arizona 85724, United States
Brea, California 92821-3075, United States
Fullerton, California 92835-3800, United States
La Jolla, California 92093, United States
Madera, California 93637, United States
Bridgeport, Connecticut 06610, United States
Farmington, Connecticut 06030, United States
Stamford, Connecticut 06902-3628, United States
Brandon, Florida 33511, United States
Jacksonville, Florida 32209, United States
Orlando, Florida 32806-2093, United States
Sarasota, Florida 34239, United States
Tampa, Florida 33606-3508, United States
Austell, Georgia 30106-8116, United States
Blue Ridge, Georgia 30513, United States
Columbus, Georgia 31902, United States
Fort Gordon, Georgia 30905, United States
Marietta, Georgia 30060, United States
Honolulu, Hawaii 96817, United States
Coeur d'Alene, Idaho 83814-4487, United States
Elk Grove Village, Illinois 60007, United States
Springfield, Illinois 62703, United States
Fort Wayne, Indiana 46802-1493, United States
Indianapolis, Indiana 46202-2879, United States
Indianapolis, Indiana 46280, United States
Lexington, Kentucky 40536, United States
New Orleans, Louisiana 70112, United States
New Orleans, Louisiana 70122, United States
New Orleans, Louisiana 70127-3154, United States
Shreveport, Louisiana 71130-4228, United States
Cumberland, Maryland 21502, United States
Kalamazoo, Michigan 49048-1666, United States
Royal Oak, Michigan 48073-6769, United States
Duluth, Minnesota 55805-1984, United States
Columbia, Missouri 65212, United States
St. Louis, Missouri 63110-1094, United States
Anaconda, Montana 59711-2718, United States
Omaha, Nebraska 68105, United States
Holmdel, New Jersey 07733, United States
Neptune, New Jersey 07753, United States
Newark, New Jersey 07712-2027, United States
Albany, New York 12208-3473, United States
Johnson City, New York 13790, United States
Kingston, New York 12401, United States
Manhasset, New York 11030-3876, United States
Mineola, New York 11501, United States
New York, New York 10029, United States
New York, New York 10016-9198, United States
Syracuse, New York 13210-2399, United States
Chapel Hill, North Carolina 27599-7065, United States
Elizabeth City, North Carolina 27909, United States
Winston-Salem, North Carolina 27103, United States
Winston-Salem, North Carolina 27157, United States
Akron, Ohio 44304, United States
Columbus, Ohio 43214-3998, United States
Dayton, Ohio 45428, United States
Lima, Ohio 45801, United States
Tulsa, Oklahoma 74136-1902, United States
Allentown, Pennsylvania 18102, United States
Beaver, Pennsylvania 15009, United States
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19102, United States
Summerville, South Carolina 29485, United States
Jackson, Tennessee 38301-3855, United States
Knoxville, Tennessee 37920, United States
Memphis, Tennessee 38104, United States
El Paso, Texas 79905-2709, United States
San Antonio, Texas 78217-0156, United States
San Antonio, Texas 78229, United States
San Antonio, Texas 78236-5300, United States
San Antonio, Texas 78284-5799, United States
Salt Lake City, Utah 84102, United States
Lynchburg, Virginia 24501-1109, United States
Norfolk, Virginia 23507, United States