Trial Condition(s):
Pneumonia
Avelox for treatment of Elderly Patients with Community Acquired Pneumonia
Bayer Identifier:
10872
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Omaha Divison VA Nebraska W.Iowa Health Care System Omaha, United States, 68105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Mary's/Duluth Clinic Health System Duluth, United States, 55805-1984 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southern Arizona Veterans Affairs Health Care System Tucson, United States, 85723 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Carolina Research Specialists Elizabeth City, United States, 27909 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayshore Community Hospital Holmdel, United States, 07733 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wellstar Infectious Disease, LLC Marietta, United States, 30060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bridgeport Hospital Bridgeport, United States, 06610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wilson Memorial Regional Medical Center Johnson City, United States, 13790 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wilford Hall US Airforce Medical Center San Antonio, United States, 78236-5300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Drexel University College of Medicine Philadelphia, United States, 19102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Florida - Jacksonville Jacksonville, United States, 32209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations TriState Medical Group, Inc. Beaver, United States, 15009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Newark Beth Israel Medical Center Newark, United States, 07712-2027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Medical Center Columbus, United States, 31902 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Veterans' Affairs Medical Center Dayton, United States, 45428 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Springhill Medical Center Mobile, United States, 36608-1798 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center of Louisiana at New Orleans New Orleans, United States, 70112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sarasota Memorial Hospital Sarasota, United States, 34239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grant/Riverside Methodist Hospital Columbus, United States, 43214-3998 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eisenhower Army Medical Center Fort Gordon, United States, 30905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lynchburg General Hospital Lynchburg, United States, 24501-1109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pulmonary Consultants of North Idaho Coeur d'Alene, United States, 83814-4487 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Springfield Clinic Springfield, United States, 62703 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Horizon Research Center, Inc. Blue Ridge, United States, 30513 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wishard Memorial Hospital Indianapolis, United States, 46202-2879 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LSU Health Sciences Center Shreveport, United States, 71130-4228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Sinai Medical Center New York, United States, 10029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Methodist Le Bonheur Healthcare Memphis, United States, 38104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pulmonary Associates of Brandon Clinical Research Brandon, United States, 33511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jackson-Madison County General Hospital Jackson, United States, 38301-3855 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Judy Stone Cumberland, United States, 21502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Anaconda Internal Medicine Clinic Anaconda, United States, 59711-2718 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jersey Shore University Medical Center Neptune, United States, 07753 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Arizona Health Science Center Tucson, United States, 85724 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Kentucky Lexington, United States, 40536 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Texas Tech University Health Science Center El Paso, United States, 79905-2709 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sacred Heart Clinical Research Allentown, United States, 18102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bellevue Hospital Center New York, United States, 10016-9198 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Upstate Medical University Syracuse, United States, 13210-2399 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wake Forest University Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations California Research Medical Group, Inc. Fullerton, United States, 92835-3800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hudson Valley Clinical Research Kingston, United States, 12401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Infectious Diseases Lima, United States, 45801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Tennessee Medical Center Knoxville, United States, 37920 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Connecticut Health Center Farmington, United States, 06030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akron Infectious Disease Akron, United States, 44304 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Burke Cunha, MD Mineola, United States, 11501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tampa General Hospital Tampa, United States, 33606-3508 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Missouri School of Medicine Columbia, United States, 65212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Penn State Milton S. Hershey Medical Center Hershey, United States, 17033-0850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations William Beaumont Hospital Royal Oak, United States, 48073-6769 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Infectious Disease of Indiana, PSC Indianapolis, United States, 46280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Shore University Hospital Manhasset, United States, 11030-3876 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Respiratory & Intensive Care Associates San Antonio, United States, 78217-0156 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Texas Veterans Health Care System San Antonio, United States, 78284-5799 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Stratton Veterans Affairs Medical Center Albany, United States, 12208-3473 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Madera Pulmonary & Sleep Disorder, Inc. Madera, United States, 93637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Francis Medical Center Honolulu, United States, 96817 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Salt Lake Regional Medical Center Salt Lake City, United States, 84102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UCSD-Clinical Trials Center La Jolla, United States, 92093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Adrian James, MD New Orleans, United States, 70122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pendleton Memorial Methodist Hospital New Orleans, United States, 70127-3154 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations San Juan VA Medical Center San Juan, United States, 00921-3201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brea Community Hospital Brea, United States, 92821-3075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Joseph Hospital Fort Wayne, United States, 46802-1493 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Borgess Medical Center Kalamazoo, United States, 49048-1666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eastern Virginia Medical School Norfolk, United States, 23507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Radiant Research Austell, United States, 30106-8116 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Francis Hospital Tulsa, United States, 74136-1902 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of North Carolina Chapel Hill, United States, 27599-7065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Stamford Hospital Stamford, United States, 06902-3628 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lung Diagnostics San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orlando Regional Medical Center Orlando, United States, 32806-2093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Barnes-Jewish Hospital St. Louis, United States, 63110-1094 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pulmonary Associates of Brandon Clinical Research Brandon, United States, 33511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations All-Trials Clinical Research Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Palmetto Clinical Research Summerville, United States, 29485 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Radiant Research Elk Grove Village, United States, 60007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Study of Avelox for Treatment of Elderly Patients with Community Acquired Pneumonia
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordingsTimeframe: First 72 hours of study participation
Secondary Outcome
- 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 HolterTimeframe: First 72 hours of study participation
- Adverse Events CollectionTimeframe: Up to 7-14 days post-therapy
- Clinical ResponseTimeframe: Day 3-5 during treament, 7-14 days post-therapy
- Mortality attributable to pneumoniaTimeframe: 7-14 days post-therapy
- Bacteriological ResponseTimeframe: 7-14 days post-therapy
- Overall cost of hospitalizationTimeframe: Up to 7-14 days post-therapy
Additional Information
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