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The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.
To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study of Blood Levels of Ceftaroline Fosamil | Other | Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftaroline fosamil | Drug | Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline. | This study has 3 primary outcome measures: plasma concentration of ceftaroline fosamil and its metabolites from blood samples after a single dose; PK profile of ceftaroline, and safety, where number of subjects with serious and non-serious adverse events and type of frequency of adverse events will be reported. | Up to 5 days |
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Inclusion Criteria:
Subjects must meet the following inclusion criteria:
Exclusion Criteria:
Subjects must NOT meet any of the following exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Phoenix | Arizona | 85008 | United States | ||
| Investigational Site |
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| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Investigational Site | Orange | California | 92868 | United States |
| Investigational Site | San Diego | California | 92123 | United States |
| Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Investigational Site | Louisville | Kentucky | 40202 | United States |
| Investigational Site | Shreveport | Louisiana | 71113 | United States |
| Investigational Site | Jackson | Mississippi | 39216 | United States |
| Investigational Site | Omaha | Nebraska | 68198 | United States |
| Investigational Site | Akron | Ohio | 44308 | United States |
| Investigational Site | Cleveland | Ohio | 44106 | United States |
| Investigational Site | Cleveland | Ohio | 44109 | United States |
| Investigational site | Toledo | Ohio | 43606 | United States |
| Investigational Site | Forth Worth | Texas | 76102 | United States |
| Investigational Site | Morgantown | West Virginia | 26506 | United States |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| 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 |
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