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Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)

Primary Purpose

Infections, Pneumonia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ceftaroline fosamil
IV Ceftriaxone and Vancomycin
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections focused on measuring Infections, Pediatrics, Teflaro, Ceftriaxone, cephalosporin, Vancomycin, Clindamycin, Amoxicillin Clavulanate, Linezolid, MRSA, pneumonia

Eligibility Criteria

2 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of CABP warranting 3 days of initial hospitalization
  • Confirmed presence of indicators of complicated CABP

Exclusion Criteria:

  • 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

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigative Site
  • Investigational Site 1
  • Investigational Site 2
  • Investigational Site 3
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftaroline fosamil

IV Ceftriaxone and Vancomycin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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) by assessing clinical stability of the subject at study day 4 and clinical outcome at End of IV, End of Treatment and Test of Cure.
Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
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)

Full Information

First Posted
August 17, 2012
Last Updated
October 5, 2015
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01669980
Brief Title
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to < 18 years who are initially hospitalized with Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Pneumonia
Keywords
Infections, Pediatrics, Teflaro, Ceftriaxone, cephalosporin, Vancomycin, Clindamycin, Amoxicillin Clavulanate, Linezolid, MRSA, pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftaroline fosamil
Arm Type
Experimental
Arm Title
IV Ceftriaxone and Vancomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ceftaroline fosamil
Other Intervention Name(s)
Teflaro, PPI-0903, TAK-599, TAK599, PPI0903
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
IV Ceftriaxone and Vancomycin
Intervention Description
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
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
between 1 and 57 days
Secondary Outcome Measure Information:
Title
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).
Description
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) by assessing clinical stability of the subject at study day 4 and clinical outcome at End of IV, End of Treatment and Test of Cure.
Time Frame
between 4 and 57 days
Title
Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
Description
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)
Time Frame
between 4 and 57 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of CABP warranting 3 days of initial hospitalization Confirmed presence of indicators of complicated CABP Exclusion Criteria: 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
Facility Information:
Facility Name
Investigational Site
City
Long Beach
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
Facility Name
Investigational Site
City
Orange County
State/Province
California
Country
United States
Facility Name
Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Investigational Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Investigational Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Investigative Site
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site 1
City
Tbilisi
Country
Georgia
Facility Name
Investigational Site 2
City
Tbilisi
Country
Georgia
Facility Name
Investigational Site 3
City
Tbilisi
Country
Georgia
Facility Name
Investigational Site
City
Donetsk
Country
Ukraine
Facility Name
Investigational Site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Investigational Site
City
Kryvyi Rih
Country
Ukraine
Facility Name
Investigational Site
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://www.cerexa.com
Description
Sponsor Homepage

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Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)

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