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

This study is currently recruiting participants.
Verified January 2014 by Cerexa, Inc.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01400867
First received: July 19, 2011
Last updated: January 2, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
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 Cerexa, Inc.:

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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 270
Study Start Date: December 2011
Estimated Study Completion Date: November 2014
Estimated 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400867

Contacts
Contact: Cerexa Trial Coordinator 510-285-9200 clinicaltrials@cerexa.com

  Show 70 Study Locations
Sponsors and Collaborators
Cerexa, Inc.
AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT01400867     History of Changes
Other Study ID Numbers: P903-23
Study First Received: July 19, 2011
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerexa, Inc.:
Infections
Pediatrics
Teflaro
cephalosporin

Additional relevant MeSH terms:
Aztreonam
Cefazolin
Cephalexin
Clindamycin
Clindamycin-2-phosphate
Vancomycin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014