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

Primary Purpose

Infections, Community Acquired Pneumonia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ceftaroline fosamil
Ceftriaxone
amoxicillin clavulanate
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, cephalosporin

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female, 2 months to < 18 years old.
  • Presence of CABP requiring hospitalization and IV antibacterial therapy

Exclusion Criteria:

  • 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.

Sites / Locations

  • Investigational Site
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  • Investigational Site2
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  • Investigational Site3
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftaroline fosamil

Ceftriaxone

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.
Clinical response by subject and by baseline pathogen at Study Day 4 in the Modified Intent-to-Treat (MITT) and Microbiological modified Intent-to Treat (mMITT) Populations Clinical stability by subject and by baseline pathogen at Study Day 4 in the MITT and mMITT Populations Clinical outcome at EOIV, EOT, and TOC in the MITT and Clinically Evaluable (CE) Populations Clinical and microbiological outcomes by subject and by pathogen at TOC in the mMITT and Microbiologically Evaluable (ME) Populations Clinical relapse at LFU in the MITT Population Emergent infections in the mMITT Population
To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.
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
February 8, 2012
Last Updated
January 12, 2015
Sponsor
Forest Laboratories
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01530763
Brief Title
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

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

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 Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
Detailed Description
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Community Acquired Pneumonia
Keywords
Infections, Pediatrics, Teflaro, cephalosporin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftaroline fosamil
Arm Type
Experimental
Arm Title
Ceftriaxone
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
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)
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
amoxicillin clavulanate
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization
Description
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.
Time Frame
Between 1 and 50 days.
Secondary Outcome Measure Information:
Title
Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.
Description
Clinical response by subject and by baseline pathogen at Study Day 4 in the Modified Intent-to-Treat (MITT) and Microbiological modified Intent-to Treat (mMITT) Populations Clinical stability by subject and by baseline pathogen at Study Day 4 in the MITT and mMITT Populations Clinical outcome at EOIV, EOT, and TOC in the MITT and Clinically Evaluable (CE) Populations Clinical and microbiological outcomes by subject and by pathogen at TOC in the mMITT and Microbiologically Evaluable (ME) Populations Clinical relapse at LFU in the MITT Population Emergent infections in the mMITT Population
Time Frame
Between 4 and 50 days
Title
To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.
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 50 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: Male or female, 2 months to < 18 years old. Presence of CABP requiring hospitalization and IV antibacterial therapy Exclusion Criteria: 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.
Facility Information:
Facility Name
Investigational Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
Investigational Site
City
Oakland
State/Province
California
Country
United States
Facility Name
Investigational Site
City
Orange
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
Syracuse
State/Province
New York
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
Pittsuburg
State/Province
Pennsylvania
Country
United States
Facility Name
Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Investigational Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Investigational Site
City
Capital Federal
State/Province
Buenos Aires
Country
Argentina
Facility Name
Investigational Site
City
Cordoba
Country
Argentina
Facility Name
Investigational Site
City
Plovdiv
Country
Bulgaria
Facility Name
Investigational Site
City
Ruse
Country
Bulgaria
Facility Name
Investigational Site2
City
Sofia
Country
Bulgaria
Facility Name
Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
Investigational Site2
City
Tbilisi
Country
Georgia
Facility Name
Investigational Site3
City
Tbilisi
Country
Georgia
Facility Name
Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
Investigational Site
City
Athens
State/Province
Attica
Country
Greece
Facility Name
Investigational Site
City
Heraklion
State/Province
Crete
Country
Greece
Facility Name
Investigational Site
City
Thessaloniki
State/Province
Macedonia
Country
Greece
Facility Name
Investigational Site
City
Larissa
State/Province
Thessaly
Country
Greece
Facility Name
Investigational Site
City
Gyula
State/Province
Bekes
Country
Hungary
Facility Name
Investigational Site
City
Ajka
Country
Hungary
Facility Name
Investigational Site
City
Budapest
Country
Hungary
Facility Name
Investigational Site
City
Nagykanisza
Country
Hungary
Facility Name
Investigational Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Investigational Site
City
Szeged
Country
Hungary
Facility Name
Investigational Site
City
Veszprem
Country
Hungary
Facility Name
Investigational Site
City
Zalaegerszeg
Country
Hungary
Facility Name
Investigational Site
City
Lublin
Country
Poland
Facility Name
Investigational Site
City
Rzeszow
Country
Poland
Facility Name
Investigational Site
City
Warsaw
Country
Poland
Facility Name
Investigational Site
City
Cordoba
Country
Spain
Facility Name
Investigational Site
City
Madrid
Country
Spain
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
Facility Name
Investigational Site
City
Zaporizhia
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
27093162
Citation
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.
Results Reference
derived
Links:
URL
http://www.cerexa.com
Description
sponsor website

Learn more about this trial

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

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