Status:
COMPLETED
Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
Lead Sponsor:
Bayer
Conditions:
Pneumonia
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief 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 \...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT00665327
Start Date
November 1 2002
End Date
April 1 2004
Last Update
November 18 2014
Active Locations (77)
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1
Mobile, Alabama, United States, 36608-1798
2
Tucson, Arizona, United States, 85723
3
Tucson, Arizona, United States, 85724
4
Brea, California, United States, 92821-3075