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

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ClinicalTrials.gov Identifier: NCT01530763
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : January 13, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Infections Community Acquired Pneumonia Drug: Ceftaroline fosamil Drug: Ceftriaxone Drug: amoxicillin clavulanate Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2012
Primary Completion Date : April 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions

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: 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)

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.)



Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530763


  Show 44 Study Locations
Sponsors and Collaborators
Forest Laboratories
AstraZeneca
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01530763     History of Changes
Other Study ID Numbers: P903-31
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015

Keywords provided by Forest Laboratories:
Infections
Pediatrics
Teflaro
cephalosporin

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Amoxicillin
Ceftriaxone
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action