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This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftriaxone | Drug | 1000mg iv daily |
| |
| beta-lactam |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate\n\n | End of study visit (7-10 days after end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, vital signs, laboratory parameters\n | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Orleans | Louisiana | 70112 | United States | |||
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| Drug |
750mg iv q 23h for 3-14 days |
|
| beta-lactam | Drug | 1500mg iv q 12h for 3-14 days |
|
| Shreveport |
| Louisiana |
| 71105 |
| United States |
| Detroit | Michigan | 48201 | United States |
| Butte | Montana | 59701 | United States |
| Holmdel | New Jersey | 07733 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Buenos Aires | 1180 | Argentina |
| Buenos Aires | 1282 | Argentina |
| Buenos Aires | 1427 | Argentina |
| Buenos Aires | 1602 | Argentina |
| Buenos Aires | 1657 | Argentina |
| Buenos Aires | 1888 | Argentina |
| Buenos Aires | BUE1430 | Argentina |
| Ciudadela | 1702 | Argentina |
| Córdoba | 5000 | Argentina |
| Córdoba | X5004CDT | Argentina |
| Granadero Baigorria | 2152 | Argentina |
| Paraná | 3100 | Argentina |
| Rosario | S2000DSV | Argentina |
| Rousse | 7002 | Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1431 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Santiago | Chile |
| Valdivia | Chile |
| Zagreb | 10000 | Croatia |
| Budapest | 1529 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Törökbálint | 2045 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Daugavpils | 5417 | Latvia |
| Riga | 1038 | Latvia |
| Riga | LV-1002 | Latvia |
| Kaunas | 3000 | Lithuania |
| Klaipėda | 92231 | Lithuania |
| Vilnius | 08661 | Lithuania |
| Lima | 11 | Peru |
| Lima | 1 | Peru |
| Lima | 31 | Peru |
| Bucharest | 030303 | Romania |
| Bucharest | 21105 | Romania |
| Bucharest | 21659 | Romania |
| Bucharest | Romania |
| Constanța | 8700 | Romania |
| Craiova | 200515 | Romania |
| Banská Bystrica | 975 17 | Slovakia |
| Nitra | 949 88 | Slovakia |
| Nitra | 950 01 | Slovakia |
| Poprad | 058 87 | Slovakia |
| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D047090 | beta-Lactams |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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