Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
NCT ID: NCT00665327
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
401 participants
INTERVENTIONAL
2002-11-30
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Avelox (Moxifloxacin, BAY12-8039)
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
Arm 2
Levofloxacin
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
Interventions
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Avelox (Moxifloxacin, BAY12-8039)
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Mobile, Alabama, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Brea, California, United States
Fullerton, California, United States
La Jolla, California, United States
Madera, California, United States
Bridgeport, Connecticut, United States
Farmington, Connecticut, United States
Stamford, Connecticut, United States
Brandon, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Austell, Georgia, United States
Blue Ridge, Georgia, United States
Columbus, Georgia, United States
Fort Gordon, Georgia, United States
Marietta, Georgia, United States
Honolulu, Hawaii, United States
Coeur d'Alene, Idaho, United States
Elk Grove Village, Illinois, United States
Springfield, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Cumberland, Maryland, United States
Kalamazoo, Michigan, United States
Royal Oak, Michigan, United States
Duluth, Minnesota, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
Anaconda, Montana, United States
Omaha, Nebraska, United States
Holmdel, New Jersey, United States
Neptune City, New Jersey, United States
Newark, New Jersey, United States
Albany, New York, United States
Johnson City, New York, United States
Kingston, New York, United States
Manhasset, New York, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Elizabeth City, North Carolina, United States
Winston-Salem, North Carolina, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Lima, Ohio, United States
Tulsa, Oklahoma, United States
Allentown, Pennsylvania, United States
Beaver, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Summerville, South Carolina, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
El Paso, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Lynchburg, Virginia, United States
Norfolk, Virginia, United States
San Juan, , Puerto Rico
Countries
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Other Identifiers
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10872
Identifier Type: -
Identifier Source: org_study_id