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

January 12, 2015 updated by: Forest Laboratories

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

This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina
        • Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina
        • Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria
        • Investigational Site
      • Ruse, Bulgaria
        • Investigational Site
      • Sofia, Bulgaria
        • Investigational Site2
      • Sofia, Bulgaria
        • Investigational Site
  • Georgia
      • Tbilisi, Georgia
        • Investigational Site2
      • Tbilisi, Georgia
        • Investigational Site3
      • Tbilisi, Georgia
        • Investigational Site
  • Greece
    • Attica
      • Athens, Attica, Greece
        • Investigational Site
    • Crete
      • Heraklion, Crete, Greece
        • Investigational Site
    • Macedonia
      • Thessaloniki, Macedonia, Greece
        • Investigational Site
    • Thessaly
      • Larissa, Thessaly, Greece
        • Investigational Site
  • Hungary
      • Ajka, Hungary
        • Investigational Site
      • Budapest, Hungary
        • Investigational Site
      • Nagykanisza, Hungary
        • Investigational Site
      • Nyiregyhaza, Hungary
        • Investigational Site
      • Szeged, Hungary
        • Investigational Site
      • Veszprem, Hungary
        • Investigational Site
      • Zalaegerszeg, Hungary
        • Investigational Site
    • Bekes
      • Gyula, Bekes, Hungary
        • Investigational Site
  • Poland
      • Lublin, Poland
        • Investigational Site
      • Rzeszow, Poland
        • Investigational Site
      • Warsaw, Poland
        • Investigational Site
  • Spain
      • Cordoba, Spain
        • Investigational Site
      • Madrid, Spain
        • Investigational Site
  • Ukraine
      • Donetsk, Ukraine
        • Investigational Site
      • Ivano-Frankivsk, Ukraine
        • Investigational Site
      • Kryvyi Rih, Ukraine
        • Investigational Site
      • Kyiv, Ukraine
        • Investigational Site
      • Zaporizhia, Ukraine
        • Investigational Site
  • United States
    • California
      • 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
    • Massachusetts
      • Boston, Massachusetts, United States
        • Investigational Site
    • New York
      • Syracuse, New York, United States
        • Investigational Site
    • Ohio
      • Cleveland, Ohio, United States
        • Investigational Site
      • Toledo, Ohio, United States
        • Investigational Site
    • Pennsylvania
      • Pittsuburg, Pennsylvania, United States
        • Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Investigational Site
    • Texas
      • Houston, Texas, United States
        • Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ceftaroline fosamil
Drug: 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)

Other Names:
  • Teflaro
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
Drug: 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.)
Active Comparator: Ceftriaxone
Drug: 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.)

Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization
Time Frame: Between 1 and 50 days.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.
Time Frame: Between 4 and 50 days
  • 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
Between 4 and 50 days
To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.
Time Frame: Between 4 and 50 days
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).
Between 4 and 50 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P903-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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