Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization
1 other identifier
interventional
161
9 countries
44
Brief Summary
This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJanuary 13, 2015
January 1, 2015
1.6 years
February 8, 2012
January 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (2)
Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.
Between 4 and 50 days
To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.
Between 4 and 50 days
Study Arms (2)
Ceftaroline fosamil
EXPERIMENTALCeftriaxone
ACTIVE COMPARATORInterventions
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)
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)
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.)
Eligibility Criteria
You may qualify if:
- Male or female, 2 months to \< 18 years old.
- Presence of CABP requiring hospitalization and IV antibacterial therapy
You may not qualify if:
- Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Forest Laboratorieslead
- AstraZenecacollaborator
Study Sites (44)
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
Related Publications (1)
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.
PMID: 27093162DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2012
First Posted
February 10, 2012
Study Start
September 1, 2012
Primary Completion
April 1, 2014
Study Completion
July 1, 2014
Last Updated
January 13, 2015
Record last verified: 2015-01