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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
401
Moxifloxacin 400 mg IV QD for a minimum of two doses followed by moxifloxacin 400 mg PO QD for a total treatment duration of 7 to 14 days
Levofloxacin 500 mg IV QD for a minimum of two doses followed by Levofloxacin 500 mg PO QD for a total treatment duration of 7 to 14 days. For patients who have a documented or calculated creatinine clearance of 20 - 49 ml/minute, the IV and PO dose of Levofloxacin will be a 500 mg loading dose followed by 250 mg QD for a total treatment duration of 7 to 14 days
Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings
Time frame: First 72 hours of study participation
Incidence of a composite safety end point (including atrial fibrillation sustained and unsustained supraventricular tachycardia, third degree AV block and long RR pauses), based on Holter
Time frame: First 72 hours of study participation
Adverse Events Collection
Time frame: Up to 7-14 days post-therapy
Clinical Response
Time frame: Day 3-5 during treament, 7-14 days post-therapy
Mortality attributable to pneumonia
Time frame: 7-14 days post-therapy
Bacteriological Response
Time frame: 7-14 days post-therapy
Overall cost of hospitalization
Time frame: Up to 7-14 days post-therapy
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Tucson, Arizona, United States
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Brea, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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Madera, California, United States
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Bridgeport, Connecticut, United States
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Stamford, Connecticut, United States
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