Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)
A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)
1 other identifier
interventional
40
4 countries
21
Brief Summary
This is a study of safety and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired 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 P25-P50 for phase_4
Started Oct 2012
21 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
August 17, 2012
CompletedFirst Posted
Study publicly available on registry
August 21, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedNovember 2, 2015
October 1, 2015
1.6 years
August 17, 2012
October 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety and tolerability of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects ages 2 months to < 18 years with complicated community-acquired bacterial pneumonia (CABP)
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with complicated CABP. Summaries of patient AEs, SAEs, deaths, discontinuations due to AEs, laboratory evaluations (hematology studies, comprehensive and metabolic panel), and vital signs will be provided for each treatment group.
between 1 and 57 days
Secondary Outcomes (2)
To evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA).
between 4 and 57 days
Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
between 4 and 57 days
Study Arms (2)
Ceftaroline fosamil
EXPERIMENTALIV Ceftriaxone and Vancomycin
ACTIVE COMPARATORInterventions
* 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 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
Eligibility Criteria
You may qualify if:
- Presence of CABP warranting 3 days of initial hospitalization
- Confirmed presence of indicators of complicated CABP
You may not qualify if:
- Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Investigational Site
Long Beach, California, United States
Unknown Facility
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
Unknown Facility
Houston, Texas, United States
Unknown Facility
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2012
First Posted
August 21, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2014
Study Completion
August 1, 2014
Last Updated
November 2, 2015
Record last verified: 2015-10