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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftaroline fosamil | Experimental |
| |
| Ceftriaxone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftaroline fosamil | Drug | Treatment Group 1: Drug: Ceftaroline fosamil Children ≥ 6 months: IV ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Children < 6 months: Ceftaroline fosamil 8 mg/kg over 60 (± 10) minutes q8h (± 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization | Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with CABP. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), vital signs. | Between 1 and 50 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP. |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Long Beach | California | United States | |||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27093162 | Derived | Cannavino CR, Nemeth A, Korczowski B, Bradley JS, O'Neal T, Jandourek A, Friedland HD, Kaplan SL. A Randomized, Prospective Study of Pediatric Patients With Community-acquired Pneumonia Treated With Ceftaroline Versus Ceftriaxone. Pediatr Infect Dis J. 2016 Jul;35(7):752-9. doi: 10.1097/INF.0000000000001159. |
| Label | URL |
|---|---|
| sponsor website | View source |
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|
|
| Ceftriaxone | Drug | Treatment group 2: 75 mg/kg/day up to 4 g/day IV in equally divided doses, each infused over 30 (± 10) minutes q12hr (± 2 hours) |
|
| amoxicillin clavulanate | Drug | Oral Switch for Treatment Groups 1 and 2: PO amoxicillin clavulanate 90 mg/kg/day divided q12h in subjects with infections due to susceptible organisms on or after Study Day 4 (a minimum of 7 IV doses required if randomized to ceftaroline.) |
|
| Between 4 and 50 days |
| To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years. | Analyze concentrations of ceftaroline, ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) in plasma, and, if available, in cerebrospinal fluid (CSF; if collected as part of standard of care). | Between 4 and 50 days |
| Oakland |
| California |
| United States |
| Investigational Site | Orange | California | United States |
| Investigational Site | San Diego | California | United States |
| Investigational Site | Boston | Massachusetts | United States |
| Investigational Site | Syracuse | New York | United States |
| Investigational Site | Cleveland | Ohio | United States |
| Investigational Site | Toledo | Ohio | United States |
| Investigational Site | Pittsuburg | Pennsylvania | United States |
| Investigational Site | Memphis | Tennessee | United States |
| Investigational Site | Houston | Texas | United States |
| Investigational Site | Salt Lake City | Utah | United States |
| Investigational Site | Morgantown | West Virginia | United States |
| Investigational Site | Capital Federal | Buenos Aires | Argentina |
| Investigational Site | Córdoba | Córdoba Province | Argentina |
| Investigational Site | Plovdiv | Bulgaria |
| Investigational Site | Rousse | Bulgaria |
| Investigational Site2 | Sofia | Bulgaria |
| Investigational Site | Sofia | Bulgaria |
| Investigational Site2 | Tbilisi | Georgia |
| Investigational Site3 | Tbilisi | Georgia |
| Investigational Site | Tbilisi | Georgia |
| Investigational Site | Athens | Attica | Greece |
| Investigational Site | Heraklion | Crete | Greece |
| Investigational Site | Thessaloniki | Macedonia | Greece |
| Investigational Site | Larissa | Thessaly | Greece |
| Investigational Site | Gyula | Bekes County | Hungary |
| Investigational Site | Ajka | Hungary |
| Investigational Site | Budapest | Hungary |
| Investigational Site | Nagykanisza | Hungary |
| Investigational Site | Nyíregyháza | Hungary |
| Investigational Site | Szeged | Hungary |
| Investigational Site | Veszprém | Hungary |
| Investigational Site | Zalaegerszeg | Hungary |
| Investigational Site | Lublin | Poland |
| Investigational Site | Rzeszów | Poland |
| Investigational Site | Warsaw | Poland |
| Investigational Site | Madrid | Madrid | Spain |
| Investigational Site | Córdoba | Spain |
| Investigational Site | Donetsk | Ukraine |
| Investigational Site | Ivano-Frankivsk | Ukraine |
| Investigational Site | Kryvyi Rih | Ukraine |
| Investigational Site | Kyiv | Ukraine |
| Investigational Site | Zaporizhia | Ukraine |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| D002443 | Ceftriaxone |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| 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 |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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