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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
To evaluate safety, effectiveness, pharmacokinetics and tolerance of Ceftaroline fosamil in children who are initially hospitalized with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftaroline fosamil | Experimental |
| |
| Comparators | Active Comparator | Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftaroline fosamil | Drug | Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Subjects < 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. | Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with skin infections. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), pain scales, vital signs, and physical examinations will be provided for each treatment group. | Between 26 and 50 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. | The number and percentage of subjects in each treatment group classified as clinical cure in the Modified Intent to Treat (MITT) and Clinical Evaluable (CE) populations at Day 3, EOIV, EOT and TOC. | Between 1 and 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site - Phoenix | Phoenix | Arizona | United States | |||
| Investigational Site - Orange |
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| Label | URL |
|---|---|
| Related Info | View source |
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|
|
| Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam | Drug | Vancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed) Cefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed |
|
| Cephalexin or Clindamycin or Linezolid | Drug | Possible oral switch on or after study day 4. Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO. |
|
| Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. |
Analyze concentrations of ceftaroline fosamil, ceftaroline, and M-1 in plasma, and if available, in cerebrospinal fluid (CSF; if collected as part of routine medical care) |
| Between 1 and 5 days |
| Orange |
| California |
| United States |
| Investigational Site - San Diego | San Diego | California | United States |
| Investigational Site - Jacksonville | Jacksonville | Florida | United States |
| Investigational Site - Atlanta | Atlanta | Georgia | United States |
| Investigational Site - Chicago 1 | Chicago | Illinois | United States |
| Investigational Site - Chicago 2 | Chicago | Illinois | United States |
| Investigational Site - Springfield | Springfield | Illinois | United States |
| Investigational Site - Shreveport | Shreveport | Louisiana | United States |
| Investigational Site - Baltimore | Baltimore | Maryland | United States |
| Investigational Site - Detroit | Detroit | Michigan | United States |
| Investigational Site - Brooklyn | Brooklyn | New York | United States |
| Investigational Site - New Hyde Park | New Hyde Park | New York | United States |
| Investigational Site - Rochester | Rochester | New York | United States |
| Investigational Site - Bronx | The Bronx | New York | United States |
| Investigational Site - Akron | Akron | Ohio | United States |
| Investigational Site - Cleveland 1 | Cleveland | Ohio | United States |
| Investigational Site - Cleveland 2 | Cleveland | Ohio | United States |
| Investigational Site - Toledo | Toledo | Ohio | United States |
| Investigational Site - Pittsburgh | Pittsburgh | Pennsylvania | United States |
| Investigational Site - Charleston | Charleston | South Carolina | United States |
| Investigational Site - Memphis | Memphis | Tennessee | United States |
| Investigational Site - Austin 1 | Austin | Texas | United States |
| Investigational Site - Fort Worth | Fort Worth | Texas | United States |
| Investigational Site - Norfolk | Norfolk | Virginia | United States |
| Investigational Site - Richmond | Richmond | Virginia | United States |
| Investigational Site - Seattle | Seattle | Washington | United States |
| Investigational Site - Morgantown | Morgantown | West Virginia | United States |
| Investigational Site - Buenos Aires 1 | Buenos Aires | Argentina |
| Investigational Site - Buenos Aires 2 | Buenos Aires | Argentina |
| Investigational Site - Buenos Aires 3 | Buenos Aires | Argentina |
| Investigational Site - Buenos Aires 4 | Buenos Aires | Argentina |
| Investigational Site - Buenos Aires 5 | Buenos Aires | Argentina |
| Investigational Site - Buenos Aires 6 | Buenos Aires | Argentina |
| Investigational Site - Santa Fe 1 | Santa Fe | Argentina |
| Investigational Site - Santa Fe 2 | Santa Fe | Argentina |
| Investigational Site - Puente Alto | Puente Alto | Santiago Metropolitan | Chile |
| Investigational Site - San Ramon | San Ramón | Santiago Metropolitan | Chile |
| Investigational Site - Vitacura | Vitacura | Santiago Metropolitan | Chile |
| Investigational Site - Vina Del Mar | Viña del Mar | Chile |
| Investigational Site - Tbilisi 1 | Tbilisi | Georgia |
| Investigational Site - Tbilisi 2 | Tbilisi | Georgia |
| Investigational Site - Daugavpils | Daugavpils | Latvia |
| Investigational Site - Liepaja | Liepāja | Latvia |
| Investigational Site - Rezekne | Rēzekne | Latvia |
| Investigational Site - Riga | Riga | Latvia |
| Investigational Site - Kaunas | Kaunas | Lithuania |
| Investigational Site - Vilnius | Vilnius | Lithuania |
| Investigational Site - Bydgoszcz 1 | Bydgoszcz | Poland |
| Investigational Site - Bydgoszcz 2 | Bydgoszcz | Poland |
| Investigational Site - Lodz | Lodz | Poland |
| Investigational Site - Lublin | Lublin | Poland |
| Investigational Site - Rzeszow | Rzeszów | Poland |
| Investigational Site - Warszawa | Warsaw | Poland |
| Investigational Site - Bucharest 1 | Bucharest | Romania |
| Investigational Site - Bucharest 2 | Bucharest | Romania |
| Investigational Site - Constanta | Constanța | Romania |
| Investigational Site - Tirgu Mures | Târgu Mureş | Romania |
| Investigational Site - Timisoara | Timișoara | Romania |
| Investigational Site - Cape Town 1 | Cape Town | South Africa |
| Investigational Site - Cape Town 2 | Cape Town | South Africa |
| Investigational Site - Cape Town 3 | Cape Town | South Africa |
| Investigational Site - Johannesburg | Johannesburg | South Africa |
| Investigational Site - Badalona | Badalona | Spain |
| Investigational Site - Esplugues de Llobregat | Esplugues de Llobregat | Spain |
| Investigational Site - Getafe | Getafe | Spain |
| Investigational Site - Madrid 1 | Madrid | Spain |
| Investigational Site - Madrid 2 | Madrid | Spain |
| Investigational Site - Madrid 3 | Madrid | Spain |
| Investigational Site - Santiago de Compostela | Santiago de Compostela | Spain |
| Investigational Site - Valencia | Valencia | Spain |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| D002506 | Cephalexin |
| D002981 | Clindamycin |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| 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 |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000081 | Acetamides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
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