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A Study of Avelox® for Treatment of Elderly Patients With Community Acquired Pneumonia

Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia

Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug); Levofloxacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

This study compared the safety and efficacy of Avelox® vs. Levaquin® for the treatment of Community Acquired Pneumonia (CAP) in patients >= 65 years of age.

Clinical Details

Official title: A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study

Primary outcome: Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings

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 Holter

Adverse Events

Clinical Response

Mortality attributable to pneumonia

Bacteriological Response

Overall cost of hospitalization

Detailed description: 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.

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

San Juan 00921-3201, Puerto Rico

Tucson, Arizona 85723, United States

Fullerton, California 92835-3800, United States

Madera, California 93637, United States

La Jolla, California 92093, United States

Brea, California 92821-3075, United States

Bridgeport, Connecticut 06610, United States

Farmington, Connecticut 06030, United States

Brandon, Florida 33511, United States

Orlando, Florida 32806-2093, United States

Fort Gordon, Georgia 30905, United States

Marietta, Georgia 30060, United States

Blue Ridge, Georgia 30513, United States

Columbus, Georgia 31902, United States

Austell, Georgia 30106-8116, United States

Coeur d'Alene, Idaho 83814-4487, United States

Springfield, Illinois 62703, United States

Indianapolis, Indiana 46202-2879, United States

New Orleans, Louisiana 70112, United States

Shreveport, Louisiana 71130-4228, United States

New Orleans, Louisiana 70127-3154, United States

Cumberland, Maryland 21502, United States

Royal Oak, Michigan 48073-6769, United States

Kalamazoo, Michigan 49048-1666, United States

Duluth, Minnesota 55805-1984, United States

Anaconda, Montana 59711-2718, United States

Holmdel, New Jersey 07733, United States

Newark, New Jersey 07712-2027, United States

New York, New York 10029, United States

Albany, New York 12208-3473, United States

Elizabeth City, North Carolina 27909, United States

Chapel Hill, North Carolina 27599-7065, United States

Winston-Salem, North Carolina 27103, United States

Dayton, Ohio 45428, United States

Columbus, Ohio 43214-3998, United States

Akron, Ohio 44304, United States

Tulsa, Oklahoma 74136-1902, United States

Beaver, Pennsylvania 15009, United States

Allentown, Pennsylvania 18102, United States

Hershey, Pennsylvania 17033-0850, United States

Summerville, South Carolina 29485, United States

Jackson, Tennessee 38301-3855, United States

San Antonio, Texas 78217-0156, United States

San Antonio, Texas 78284-5799, United States

San Antonio, Texas 78229, United States

Salt Lake City, Utah 84102, United States

Lynchburg, Virginia 24501-1109, United States

Additional Information

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Starting date: November 2002
Ending date: April 2004
Last updated: April 22, 2008

Page last updated: June 20, 2008

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