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

October 5, 2015 updated by: Forest Laboratories

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)

This is a study of safety and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired 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 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)

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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
      • Buenos Aires, Argentina
        • Investigative Site
  • Georgia
      • Tbilisi, Georgia
        • Investigational Site 1
      • Tbilisi, Georgia
        • Investigational Site 2
      • Tbilisi, Georgia
        • Investigational Site 3
  • Ukraine
      • Donetsk, Ukraine
        • Investigational Site
      • Ivano-Frankivsk, Ukraine
        • Investigational Site
      • Kryvyi Rih, Ukraine
        • Investigational Site
      • Kyiv, Ukraine
        • Investigational Site
  • United States
    • California
      • Long Beach, California, United States
        • Investigational Site
      • Oakland, California, United States
      • Orange County, California, United States
        • Investigational Site
      • San Diego, California, United States
        • Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Investigational Site
    • Ohio
      • Cleveland, Ohio, United States
        • Investigational Site
      • Toledo, Ohio, United States
        • Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Investigational Site
    • Texas
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, 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:

  • 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

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
  • 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
Other Names:
  • Teflaro
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
Active Comparator: IV Ceftriaxone and Vancomycin
Drug: IV Ceftriaxone and Vancomycin
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: between 1 and 57 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: between 4 and 57 days
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.
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)
Time Frame: between 4 and 57 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 57 days

Collaborators and Investigators

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

Sponsor

Forest Laboratories

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.

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

October 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 20, 2012

First Posted (Estimate)

August 21, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P903-24

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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