Trial Condition(s):

Pneumonia

Avelox for treatment of Elderly Patients with Community Acquired Pneumonia

Bayer Identifier:

10872

ClinicalTrials.gov Identifier:

NCT00665327

EudraCT Number:

Not Available

Study Completed

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
401
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Omaha Divison VA Nebraska W.Iowa Health Care System

Omaha, United States, 68105

Status
Terminated
 
Locations

St. Mary's/Duluth Clinic Health System

Duluth, United States, 55805-1984

Status
Completed
 
Locations

Southern Arizona Veterans Affairs Health Care System

Tucson, United States, 85723

Status
Completed
 
Locations

Carolina Research Specialists

Elizabeth City, United States, 27909

Status
Completed
 
Locations

Bayshore Community Hospital

Holmdel, United States, 07733

Status
Completed
 
Locations

Wellstar Infectious Disease, LLC

Marietta, United States, 30060

Status
Completed
 
Locations

Bridgeport Hospital

Bridgeport, United States, 06610

Status
Completed
 
Locations

Wilson Memorial Regional Medical Center

Johnson City, United States, 13790

Status
Terminated
 
Locations

Wilford Hall US Airforce Medical Center

San Antonio, United States, 78236-5300

Status
Terminated
 
Locations

Drexel University College of Medicine

Philadelphia, United States, 19102

Status
Terminated
 
Locations

University of Florida - Jacksonville

Jacksonville, United States, 32209

Status
Terminated
 
Locations

TriState Medical Group, Inc.

Beaver, United States, 15009

Status
Completed
 
Locations

Newark Beth Israel Medical Center

Newark, United States, 07712-2027

Status
Completed
 
Locations

The Medical Center

Columbus, United States, 31902

Status
Completed
 
Locations

Veterans' Affairs Medical Center

Dayton, United States, 45428

Status
Completed
 
Locations

Springhill Medical Center

Mobile, United States, 36608-1798

Status
Terminated
 
Locations

Medical Center of Louisiana at New Orleans

New Orleans, United States, 70112

Status
Completed
 
Locations

Sarasota Memorial Hospital

Sarasota, United States, 34239

Status
Terminated
 
Locations

Grant/Riverside Methodist Hospital

Columbus, United States, 43214-3998

Status
Completed
 
Locations

Eisenhower Army Medical Center

Fort Gordon, United States, 30905

Status
Completed
 
Locations

Lynchburg General Hospital

Lynchburg, United States, 24501-1109

Status
Completed
 
Locations

Pulmonary Consultants of North Idaho

Coeur d'Alene, United States, 83814-4487

Status
Completed
 
Locations

Springfield Clinic

Springfield, United States, 62703

Status
Completed
 
Locations

Horizon Research Center, Inc.

Blue Ridge, United States, 30513

Status
Completed
 
Locations

Wishard Memorial Hospital

Indianapolis, United States, 46202-2879

Status
Completed
 
Locations

LSU Health Sciences Center

Shreveport, United States, 71130-4228

Status
Completed
 
Locations

Mount Sinai Medical Center

New York, United States, 10029

Status
Completed
 
Locations

Methodist Le Bonheur Healthcare

Memphis, United States, 38104

Status
Terminated
 
Locations

Pulmonary Associates of Brandon Clinical Research

Brandon, United States, 33511

Status
Completed
 
Locations

Jackson-Madison County General Hospital

Jackson, United States, 38301-3855

Status
Completed
 
Locations

Office of Dr. Judy Stone

Cumberland, United States, 21502

Status
Completed
 
Locations

Anaconda Internal Medicine Clinic

Anaconda, United States, 59711-2718

Status
Completed
 
Locations

Jersey Shore University Medical Center

Neptune, United States, 07753

Status
Terminated
 
Locations

University of Arizona Health Science Center

Tucson, United States, 85724

Status
Terminated
 
Locations

University of Kentucky

Lexington, United States, 40536

Status
Terminated
 
Locations

Texas Tech University Health Science Center

El Paso, United States, 79905-2709

Status
Terminated
 
Locations

Sacred Heart Clinical Research

Allentown, United States, 18102

Status
Completed
 
Locations

Bellevue Hospital Center

New York, United States, 10016-9198

Status
Terminated
 
Locations

Upstate Medical University

Syracuse, United States, 13210-2399

Status
Terminated
 
Locations

Wake Forest University

Winston-Salem, United States, 27157

Status
Terminated
 
Locations

California Research Medical Group, Inc.

Fullerton, United States, 92835-3800

Status
Completed
 
Locations

Hudson Valley Clinical Research

Kingston, United States, 12401

Status
Terminated
 
Locations

Regional Infectious Diseases

Lima, United States, 45801

Status
Terminated
 
Locations

University of Tennessee Medical Center

Knoxville, United States, 37920

Status
Terminated
 
Locations

University of Connecticut Health Center

Farmington, United States, 06030

Status
Completed
 
Locations

Akron Infectious Disease

Akron, United States, 44304

Status
Completed
 
Locations

Office of Dr. Burke Cunha, MD

Mineola, United States, 11501

Status
Terminated
 
Locations

Tampa General Hospital

Tampa, United States, 33606-3508

Status
Terminated
 
Locations

University of Missouri School of Medicine

Columbia, United States, 65212

Status
Terminated
 
Locations

Penn State Milton S. Hershey Medical Center

Hershey, United States, 17033-0850

Status
Completed
 
Locations

William Beaumont Hospital

Royal Oak, United States, 48073-6769

Status
Completed
 
Locations

Infectious Disease of Indiana, PSC

Indianapolis, United States, 46280

Status
Terminated
 
Locations

North Shore University Hospital

Manhasset, United States, 11030-3876

Status
Terminated
 
Locations

Respiratory & Intensive Care Associates

San Antonio, United States, 78217-0156

Status
Completed
 
Locations

South Texas Veterans Health Care System

San Antonio, United States, 78284-5799

Status
Completed
 
Locations

Stratton Veterans Affairs Medical Center

Albany, United States, 12208-3473

Status
Completed
 
Locations

Madera Pulmonary & Sleep Disorder, Inc.

Madera, United States, 93637

Status
Completed
 
Locations

St. Francis Medical Center

Honolulu, United States, 96817

Status
Terminated
 
Locations

Salt Lake Regional Medical Center

Salt Lake City, United States, 84102

Status
Completed
 
Locations

UCSD-Clinical Trials Center

La Jolla, United States, 92093

Status
Completed
 
Locations

Office of Dr. Adrian James, MD

New Orleans, United States, 70122

Status
Terminated
 
Locations

Pendleton Memorial Methodist Hospital

New Orleans, United States, 70127-3154

Status
Completed
 
Locations

San Juan VA Medical Center

San Juan, United States, 00921-3201

Status
Completed
 
Locations

Brea Community Hospital

Brea, United States, 92821-3075

Status
Completed
 
Locations

St. Joseph Hospital

Fort Wayne, United States, 46802-1493

Status
Terminated
 
Locations

Borgess Medical Center

Kalamazoo, United States, 49048-1666

Status
Completed
 
Locations

Eastern Virginia Medical School

Norfolk, United States, 23507

Status
Terminated
 
Locations

Radiant Research

Austell, United States, 30106-8116

Status
Completed
 
Locations

St. Francis Hospital

Tulsa, United States, 74136-1902

Status
Completed
 
Locations

University of North Carolina

Chapel Hill, United States, 27599-7065

Status
Completed
 
Locations

Stamford Hospital

Stamford, United States, 06902-3628

Status
Terminated
 
Locations

Lung Diagnostics

San Antonio, United States, 78229

Status
Completed
 
Locations

Orlando Regional Medical Center

Orlando, United States, 32806-2093

Status
Completed
 
Locations

Barnes-Jewish Hospital

St. Louis, United States, 63110-1094

Status
Terminated
 
Locations

Pulmonary Associates of Brandon Clinical Research

Brandon, United States, 33511

Status
Terminated
 
Locations

All-Trials Clinical Research

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Palmetto Clinical Research

Summerville, United States, 29485

Status
Completed
 
Locations

Radiant Research

Elk Grove Village, United States, 60007

Status
Terminated
 

Trial Design