check_circleStudy Completed
Pneumonia
Bayer Identifier:
10872
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Avelox for treatment of Elderly Patients with Community Acquired Pneumonia
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.
Key Participants Requirements
Sex
BothAge
65 YearsTrial summary
Enrollment Goal
401Trial Dates
November 2002 - April 2004Phase
Phase 4Could I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Omaha Divison VA Nebraska W.Iowa Health Care System | Omaha, 68105, United States |
Completed | St. Mary's/Duluth Clinic Health System | Duluth, 55805-1984, United States |
Completed | Southern Arizona Veterans Affairs Health Care System | Tucson, 85723, United States |
Completed | Carolina Research Specialists | Elizabeth City, 27909, United States |
Completed | Bayshore Community Hospital | Holmdel, 07733, United States |
Completed | Wellstar Infectious Disease, LLC | Marietta, 30060, United States |
Completed | Bridgeport Hospital | Bridgeport, 06610, United States |
Terminated | Wilson Memorial Regional Medical Center | Johnson City, 13790, United States |
Terminated | Wilford Hall US Airforce Medical Center | San Antonio, 78236-5300, United States |
Terminated | Drexel University College of Medicine | Philadelphia, 19102, United States |
Terminated | University of Florida - Jacksonville | Jacksonville, 32209, United States |
Completed | TriState Medical Group, Inc. | Beaver, 15009, United States |
Completed | Newark Beth Israel Medical Center | Newark, 07712-2027, United States |
Completed | The Medical Center | Columbus, 31902, United States |
Completed | Veterans' Affairs Medical Center | Dayton, 45428, United States |
Terminated | Springhill Medical Center | Mobile, 36608-1798, United States |
Completed | Medical Center of Louisiana at New Orleans | New Orleans, 70112, United States |
Terminated | Sarasota Memorial Hospital | Sarasota, 34239, United States |
Completed | Grant/Riverside Methodist Hospital | Columbus, 43214-3998, United States |
Completed | Eisenhower Army Medical Center | Fort Gordon, 30905, United States |
Completed | Lynchburg General Hospital | Lynchburg, 24501-1109, United States |
Completed | Pulmonary Consultants of North Idaho | Coeur d'Alene, 83814-4487, United States |
Completed | Springfield Clinic | Springfield, 62703, United States |
Completed | Horizon Research Center, Inc. | Blue Ridge, 30513, United States |
Completed | Wishard Memorial Hospital | Indianapolis, 46202-2879, United States |
Completed | LSU Health Sciences Center | Shreveport, 71130-4228, United States |
Completed | Mount Sinai Medical Center | New York, 10029, United States |
Terminated | Methodist Le Bonheur Healthcare | Memphis, 38104, United States |
Completed | Pulmonary Associates of Brandon Clinical Research | Brandon, 33511, United States |
Completed | Jackson-Madison County General Hospital | Jackson, 38301-3855, United States |
Completed | Office of Dr. Judy Stone | Cumberland, 21502, United States |
Completed | Anaconda Internal Medicine Clinic | Anaconda, 59711-2718, United States |
Terminated | Wilford Hall US Airforce Medical Center | San Antonio, 78236-5300, United States |
Terminated | Jersey Shore University Medical Center | Neptune, 07753, United States |
Terminated | University of Arizona Health Science Center | Tucson, 85724, United States |
Terminated | University of Kentucky | Lexington, 40536, United States |
Terminated | Texas Tech University Health Science Center | El Paso, 79905-2709, United States |
Completed | Sacred Heart Clinical Research | Allentown, 18102, United States |
Terminated | Bellevue Hospital Center | New York, 10016-9198, United States |
Terminated | Upstate Medical University | Syracuse, 13210-2399, United States |
Terminated | Wake Forest University | Winston-Salem, 27157, United States |
Completed | California Research Medical Group, Inc. | Fullerton, 92835-3800, United States |
Terminated | Hudson Valley Clinical Research | Kingston, 12401, United States |
Terminated | Regional Infectious Diseases | Lima, 45801, United States |
Terminated | University of Tennessee Medical Center | Knoxville, 37920, United States |
Completed | University of Connecticut Health Center | Farmington, 06030, United States |
Completed | Akron Infectious Disease | Akron, 44304, United States |
Terminated | Office of Dr. Burke Cunha, MD | Mineola, 11501, United States |
Terminated | Tampa General Hospital | Tampa, 33606-3508, United States |
Terminated | University of Missouri School of Medicine | Columbia, 65212, United States |
Completed | Penn State Milton S. Hershey Medical Center | Hershey, 17033-0850, United States |
Completed | William Beaumont Hospital | Royal Oak, 48073-6769, United States |
Terminated | Infectious Disease of Indiana, PSC | Indianapolis, 46280, United States |
Terminated | North Shore University Hospital | Manhasset, 11030-3876, United States |
Terminated | Regional Infectious Diseases | Lima, 45801, United States |
Completed | Respiratory & Intensive Care Associates | San Antonio, 78217-0156, United States |
Completed | South Texas Veterans Health Care System | San Antonio, 78284-5799, United States |
Completed | Stratton Veterans Affairs Medical Center | Albany, 12208-3473, United States |
Completed | Madera Pulmonary & Sleep Disorder, Inc. | Madera, 93637, United States |
Terminated | St. Francis Medical Center | Honolulu, 96817, United States |
Completed | Salt Lake Regional Medical Center | Salt Lake City, 84102, United States |
Completed | UCSD-Clinical Trials Center | La Jolla, 92093, United States |
Terminated | Office of Dr. Adrian James, MD | New Orleans, 70122, United States |
Completed | Pendleton Memorial Methodist Hospital | New Orleans, 70127-3154, United States |
Completed | San Juan VA Medical Center | San Juan, 00921-3201, United States |
Completed | Brea Community Hospital | Brea, 92821-3075, United States |
Terminated | St. Joseph Hospital | Fort Wayne, 46802-1493, United States |
Completed | Borgess Medical Center | Kalamazoo, 49048-1666, United States |
Terminated | Eastern Virginia Medical School | Norfolk, 23507, United States |
Completed | Radiant Research | Austell, 30106-8116, United States |
Completed | St. Francis Hospital | Tulsa, 74136-1902, United States |
Completed | University of North Carolina | Chapel Hill, 27599-7065, United States |
Terminated | Stamford Hospital | Stamford, 06902-3628, United States |
Completed | Lung Diagnostics | San Antonio, 78229, United States |
Completed | Orlando Regional Medical Center | Orlando, 32806-2093, United States |
Terminated | Barnes-Jewish Hospital | St. Louis, 63110-1094, United States |
Terminated | Pulmonary Associates of Brandon Clinical Research | Brandon, 33511, United States |
Completed | All-Trials Clinical Research | Winston-Salem, 27103, United States |
Completed | Palmetto Clinical Research | Summerville, 29485, United States |
Terminated | Radiant Research | Elk Grove Village, 60007, United States |
Primary Outcome
- Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordingsdate_rangeTime Frame:First 72 hours of study participationenhanced_encryptionyesSafety Issue:
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 Holterdate_rangeTime Frame:First 72 hours of study participationenhanced_encryptionyesSafety Issue:
- Adverse Events Collectiondate_rangeTime Frame:Up to 7-14 days post-therapyenhanced_encryptionyesSafety Issue:
- Clinical Responsedate_rangeTime Frame:Day 3-5 during treament, 7-14 days post-therapyenhanced_encryptionnoSafety Issue:
- Mortality attributable to pneumoniadate_rangeTime Frame:7-14 days post-therapyenhanced_encryptionyesSafety Issue:
- Bacteriological Responsedate_rangeTime Frame:7-14 days post-therapyenhanced_encryptionnoSafety Issue:
- Overall cost of hospitalizationdate_rangeTime Frame:Up to 7-14 days post-therapyenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2