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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelox (Moxifloxacin, BAY12-8039) | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings | First 72 hours of study participation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | First 72 hours of study participation | |
| Adverse Events Collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608-1798 | United States | |||
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| Levofloxacin | Drug | 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 |
|
| Up to 7-14 days post-therapy |
| Clinical Response | Day 3-5 during treament, 7-14 days post-therapy |
| Mortality attributable to pneumonia | 7-14 days post-therapy |
| Bacteriological Response | 7-14 days post-therapy |
| Overall cost of hospitalization | Up to 7-14 days post-therapy |
| Tucson |
| Arizona |
| 85723 |
| United States |
| Tucson | Arizona | 85724 | United States |
| Brea | California | 92821-3075 | United States |
| Fullerton | California | 92835-3800 | United States |
| La Jolla | California | 92093 | United States |
| Madera | California | 93637 | United States |
| Bridgeport | Connecticut | 06610 | United States |
| Farmington | Connecticut | 06030 | United States |
| Stamford | Connecticut | 06902-3628 | United States |
| Brandon | Florida | 33511 | United States |
| Jacksonville | Florida | 32209 | United States |
| Orlando | Florida | 32806-2093 | United States |
| Sarasota | Florida | 34239 | United States |
| Tampa | Florida | 33606-3508 | United States |
| Austell | Georgia | 30106-8116 | United States |
| Blue Ridge | Georgia | 30513 | United States |
| Columbus | Georgia | 31902 | United States |
| Fort Gordon | Georgia | 30905 | United States |
| Marietta | Georgia | 30060 | United States |
| Honolulu | Hawaii | 96817 | United States |
| Coeur d'Alene | Idaho | 83814-4487 | United States |
| Elk Grove Village | Illinois | 60007 | United States |
| Springfield | Illinois | 62703 | United States |
| Fort Wayne | Indiana | 46802-1493 | United States |
| Indianapolis | Indiana | 46202-2879 | United States |
| Indianapolis | Indiana | 46280 | United States |
| Lexington | Kentucky | 40536 | United States |
| New Orleans | Louisiana | 70112 | United States |
| New Orleans | Louisiana | 70122 | United States |
| New Orleans | Louisiana | 70127-3154 | United States |
| Shreveport | Louisiana | 71130-4228 | United States |
| Cumberland | Maryland | 21502 | United States |
| Kalamazoo | Michigan | 49048-1666 | United States |
| Royal Oak | Michigan | 48073-6769 | United States |
| Duluth | Minnesota | 55805-1984 | United States |
| Columbia | Missouri | 65212 | United States |
| St Louis | Missouri | 63110-1094 | United States |
| Anaconda | Montana | 59711-2718 | United States |
| Omaha | Nebraska | 68105 | United States |
| Holmdel | New Jersey | 07733 | United States |
| Neptune City | New Jersey | 07753 | United States |
| Newark | New Jersey | 07712-2027 | United States |
| Albany | New York | 12208-3473 | United States |
| Johnson City | New York | 13790 | United States |
| Kingston | New York | 12401 | United States |
| Manhasset | New York | 11030-3876 | United States |
| Mineola | New York | 11501 | United States |
| New York | New York | 10016-9198 | United States |
| New York | New York | 10029 | United States |
| Syracuse | New York | 13210-2399 | United States |
| Chapel Hill | North Carolina | 27599-7065 | United States |
| Elizabeth City | North Carolina | 27909 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Akron | Ohio | 44304 | United States |
| Columbus | Ohio | 43214-3998 | United States |
| Dayton | Ohio | 45428 | United States |
| Lima | Ohio | 45801 | United States |
| Tulsa | Oklahoma | 74136-1902 | United States |
| Allentown | Pennsylvania | 18102 | United States |
| Beaver | Pennsylvania | 15009 | United States |
| Hershey | Pennsylvania | 17033-0850 | United States |
| Philadelphia | Pennsylvania | 19102 | United States |
| Summerville | South Carolina | 29485 | United States |
| Jackson | Tennessee | 38301-3855 | United States |
| Knoxville | Tennessee | 37920 | United States |
| Memphis | Tennessee | 38104 | United States |
| El Paso | Texas | 79905-2709 | United States |
| San Antonio | Texas | 78217-0156 | United States |
| San Antonio | Texas | 78229 | United States |
| San Antonio | Texas | 78236-5300 | United States |
| San Antonio | Texas | 78284-5799 | United States |
| Salt Lake City | Utah | 84102 | United States |
| Lynchburg | Virginia | 24501-1109 | United States |
| Norfolk | Virginia | 23507 | United States |
| San Juan | 00921-3201 | Puerto Rico |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017714 | Community-Acquired Infections |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015242 | Ofloxacin |
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