Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)
NCT ID: NCT01669980
Last Updated: 2015-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2012-10-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ceftaroline fosamil
Ceftaroline fosamil
* Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if \> 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour)
* Subjects \< 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour)
Optional Oral Switch:
* PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
* PO clindamycin 13 mg/kg/dose
* PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
IV Ceftriaxone and Vancomycin
IV Ceftriaxone and Vancomycin
* IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND
* IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes.
Optional Oral Switch:
* PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
* PO clindamycin 13 mg/kg/dose
* PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
Interventions
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Ceftaroline fosamil
* Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if \> 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour)
* Subjects \< 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour)
Optional Oral Switch:
* PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
* PO clindamycin 13 mg/kg/dose
* PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
IV Ceftriaxone and Vancomycin
* IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND
* IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes.
Optional Oral Switch:
* PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
* PO clindamycin 13 mg/kg/dose
* PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed presence of indicators of complicated CABP
Exclusion Criteria
* Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism
* Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia
* Non-infectious causes of pulmonary infiltrates
2 Months
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Locations
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Investigational Site
Long Beach, California, United States
Oakland, California, United States
Investigational Site
Orange County, California, United States
Investigational Site
San Diego, California, United States
Investigational Site
Boston, Massachusetts, United States
Investigational Site
Cleveland, Ohio, United States
Investigational Site
Toledo, Ohio, United States
Investigational Site
Pittsburgh, Pennsylvania, United States
Investigational Site
Memphis, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Investigational Site
Norfolk, Virginia, United States
Investigational Site
Morgantown, West Virginia, United States
Investigative Site
Buenos Aires, , Argentina
Investigational Site 1
Tbilisi, , Georgia
Investigational Site 2
Tbilisi, , Georgia
Investigational Site 3
Tbilisi, , Georgia
Investigational Site
Donetsk, , Ukraine
Investigational Site
Ivano-Frankivsk, , Ukraine
Investigational Site
Kryvyi Rih, , Ukraine
Investigational Site
Kyiv, , Ukraine
Countries
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Related Links
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Sponsor Homepage
Other Identifiers
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P903-24
Identifier Type: -
Identifier Source: org_study_id
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