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NCT Number: NCT01530763

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

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

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Key information

Conditions

Infections Community Acquired Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Investigational Site, Capital Federal, Buenos Aires, Argentina

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ceftaroline fosamil

Drug

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

Ceftriaxone

Drug

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)

amoxicillin clavulanate

Drug

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 10, 2012
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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