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This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin]. The anticipated time on study treatment is <3 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 |
|---|---|---|---|---|
| Standard care | Drug | As prescribed |
| |
| beta-lactam |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate. | Event driven |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical cure | Event driven | |
| Time to resolution of signs and symptoms of skin or soft tissue infection | Event driven | |
| Bacteriological outcome |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35209 | United States | |||
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| Drug |
750mg iv q8h |
|
| beta-lactam | Drug | 1500mg iv q8h |
|
| Event driven |
| Adverse events; laboratory abnormalities | Throughout study |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Melbourne | Florida | 32901 | United States |
| Miami Beach | Florida | 33139 | United States |
| Detroit | Michigan | 48201 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Minneapolis | Minnesota | 55422 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Buenos Aires | 1282 | Argentina |
| Buenos Aires | 1430 | Argentina |
| Buenos Aires | 1657 | Argentina |
| Buenos Aires | 1888 | Argentina |
| Ciudadela | 1702 | Argentina |
| Córdoba | 5000 | Argentina |
| Córdoba | X5004CDT | Argentina |
| El Palomar | 1684 | Argentina |
| Entre Ríos | 3100 | Argentina |
| Granadero Baigorria | 2152 | Argentina |
| Merlo | 1722 | Argentina |
| Neuquén | 8300 | Argentina |
| Rosario | 2000 | Argentina |
| Rosario | S2000DSV | Argentina |
| Santa Fe | 3000 | Argentina |
| Pleven | 5800 | Bulgaria |
| Plovdiv | 4002 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Varna | 9000 | Bulgaria |
| Tallinn | 11312 | Estonia |
| Tallinn | 13419 | Estonia |
| Tartu | 51014 | Estonia |
| Lübeck | 23538 | Germany |
| Mainz | 55131 | Germany |
| München | 81377 | Germany |
| Münster | 48157 | Germany |
| Budapest | 1076 | Hungary |
| Budapest | H-1082 | Hungary |
| Győr | 9024 | Hungary |
| Liepāja | 3402 | Latvia |
| Riga | 1001 | Latvia |
| Riga | 1002 | Latvia |
| Riga | 1038 | Latvia |
| Kaunas | 50009 | Lithuania |
| Klaipėda | 92288 | Lithuania |
| Vilnius | 04130 | Lithuania |
| Vilnius | 08661 | Lithuania |
| Vilnius | 10207 | Lithuania |
| La Victoria, Lima | Lima 13 | Peru |
| Lima | 11 | Peru |
| Lima | 1 | Peru |
| Lima | Peru |
| Bucharest | 014461 | Romania |
| Bucharest | 041914 | Romania |
| Cluj-Napoca | 400006 | Romania |
| Constanța | 900591 | Romania |
| Târgu Mureş | 540342 | Romania |
| Benoni | 1501 | South Africa |
| Cape Town | 7530 | South Africa |
| Middleburg | 1050 | South Africa |
| Port Elizabeth | 6020 | South Africa |
| Pretoria | 0082 | South Africa |
| Sommerset West | 7130 | South Africa |
| Themba | 0040 | South Africa |
| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D047090 | beta-Lactams |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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