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A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin plus ceftriaxone group (AZY+CEF group) | Experimental | IV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy |
|
| Levofloxacin group (LEV group) | Experimental | IV levofloxacin (500 mg once daily) for a minimum of 2 days followed by oral levofloxacin (500 mg once daily) to complete a total of 7 to 14 days of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV azithromycin | Drug | 500 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of sequential therapy with IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® (levofloxacin) followed by oral Levaquin® in the treatment of moderate to severely ill subjects with community-acquired pneumonia. | Duration of trial |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toleration of IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® followed by oral Levaquin®, and to compare the bacteriological response rates in subjects with a baseline pathogen. | Duration of trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| Pfizer Investigational Site |
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| ceftriaxone | Drug | 1 gram once daily for 2 to 5 days |
|
|
| oral azithromycin | Drug | 2 x 250 mg once daily |
|
|
| IV levofloxacin | Drug | 500 mg once daily |
|
|
| oral levofloxacin | Drug | 500 mg once daily |
|
|
| Long Beach |
| California |
| 90822 |
| United States |
| Pfizer Investigational Site | Sylmar | California | 91342 | United States |
| Pfizer Investigational Site | Sarasota | Florida | 34339 | United States |
| Pfizer Investigational Site | Columbus | Georgia | 31902 | United States |
| Pfizer Investigational Site | Columbus | Georgia | 31904 | United States |
| Pfizer Investigational Site | Fort Eisenhower | Georgia | 30905 | United States |
| Pfizer Investigational Site | Shawnee Mission | Kansas | 66204 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40206 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48202 | United States |
| Pfizer Investigational Site | Royal Oak | Michigan | 48073-6769 | United States |
| Pfizer Investigational Site | Kirkwood | Missouri | 63122 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87108-5154 | United States |
| Pfizer Investigational Site | Mineola | New York | 11501 | United States |
| Pfizer Investigational Site | New York | New York | 10003 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43202 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| Pfizer Investigational Site | Sellersville | Pennsylvania | 18960 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Pfizer Investigational Site | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8V 1C3 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 4G5 | Canada |
| Pfizer Investigational Site | Ottawa | Ontario | K1Y 4E9 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H1T 2M4 | Canada |
| Pfizer Investigational Site | Ste-foy | Quebec | G1V 4G5 | Canada |
| Pfizer Investigational Site | Regina | Saskatchewan | S4P 1Z7 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7L 2W1 | Canada |
| Pfizer Investigational Site | Rotenburg (Wümme) | Lower Saxony | D-27356 | Germany |
| Pfizer Investigational Site | Berlin | State of Berlin | D-14109 | Germany |
| Pfizer Investigational Site | Lüdenscheid | D58515 | Germany |
| Pfizer Investigational Site | Maroussi. Attikis | Athens | 15126 | Greece |
| Pfizer Investigational Site | Barcelona | Catalonia | 08036 | Spain |
| Pfizer Investigational Site | Tarrasa | Catalonia | 08221 | Spain |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D002443 | Ceftriaxone |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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