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NCT Number: NCT01669980

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired 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.

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Key information

Conditions

Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Site, Buenos Aires, Argentina

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About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ceftaroline fosamil

Drug
  • 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

IV Ceftriaxone and Vancomycin

Drug
  • 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2012
Registry last updated
Nov 2, 2015

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

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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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