Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
NCT ID: NCT01530763
Last Updated: 2015-01-13
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
PHASE2/PHASE3
161 participants
INTERVENTIONAL
2012-09-30
2014-07-31
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
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)
amoxicillin clavulanate
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.)
Ceftriaxone
Ceftriaxone
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
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.)
Interventions
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Ceftaroline fosamil
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)
Ceftriaxone
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
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.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of CABP requiring hospitalization and IV antibacterial therapy
Exclusion Criteria
* Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.
* Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.
* Non-infectious causes of pulmonary infiltrates.
2 Months
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Locations
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Investigational Site
Long Beach, California, United States
Investigational Site
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
Countries
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References
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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.
Related Links
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sponsor website
Other Identifiers
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P903-31
Identifier Type: -
Identifier Source: org_study_id
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