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Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01400867
First received: July 19, 2011
Last updated: January 12, 2015
Last verified: January 2015
  Purpose
This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.

Condition Intervention Phase
Infections, Pediatrics Drug: Ceftaroline fosamil Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam Drug: Cephalexin or Clindamycin or Linezolid Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. [ Time Frame: Between 26 and 50 days. ]
    Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with skin infections. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), pain scales, vital signs, and physical examinations will be provided for each treatment group.


Secondary Outcome Measures:
  • Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. [ Time Frame: Between 1 and 5 days ]
    The number and percentage of subjects in each treatment group classified as clinical cure in the Modified Intent to Treat (MITT) and Clinical Evaluable (CE) populations at Day 3, EOIV, EOT and TOC.

  • Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. [ Time Frame: Between 1 and 5 days ]
    Analyze concentrations of ceftaroline fosamil, ceftaroline, and M-1 in plasma, and if available, in cerebrospinal fluid (CSF; if collected as part of routine medical care)


Enrollment: 163
Study Start Date: December 2011
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftaroline fosamil Drug: Ceftaroline fosamil

Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)

Subjects < 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)

Other Names:
  • Teflaro
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
Drug: Cephalexin or Clindamycin or Linezolid

Possible oral switch on or after study day 4.

Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO.

Active Comparator: Comparators
Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam

Vancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed)

Cefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed

Drug: Cephalexin or Clindamycin or Linezolid

Possible oral switch on or after study day 4.

Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO.


Detailed Description:
To evaluate safety, effectiveness, pharmacokinetics and tolerance of Ceftaroline fosamil in children who are initially hospitalized with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
  Eligibility

Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 2 months to < 18 years old.
  • Presence of ABSSSI warranting initial hospitalization.
  • Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention

Exclusion Criteria:

  • Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial
  • Uncomplicated skin and soft tissue infections
  • More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization.
  • Requirement for any concomitant systemic antimicrobial therapy
  • History of seizures, excluding well-documented febrile seizure of childhood.
  • Clinical signs or suspicion of meningitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400867

  Show 71 Study Locations
Sponsors and Collaborators
Forest Laboratories
AstraZeneca
  More Information

Additional Information:
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01400867     History of Changes
Other Study ID Numbers: P903-23
Study First Received: July 19, 2011
Last Updated: January 12, 2015

Keywords provided by Forest Laboratories:
Infections
Pediatrics
Teflaro
cephalosporin

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cephalexin
Aztreonam
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Vancomycin
Linezolid
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 27, 2017