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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01400867
First received: July 19, 2011
Last updated: April 16, 2014
Last verified: April 2014

July 19, 2011
April 16, 2014
December 2011
May 2014   (final data collection date for primary outcome measure)
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.
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 and coagulation studies, comprehensive metabolic panel, and urinalysis), pain scales, vital signs, and physical examinations will be provided for each treatment group.
Complete list of historical versions of study NCT01400867 on ClinicalTrials.gov Archive Site
  • 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)
  • Evaluate the efficacy 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: No ]
    The number and percentage of subjects in each treatment group classified as clinical cure in the Modified Intent to Treat (MITT) and Clinically 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 26 and 50 days ] [ Designated as safety issue: No ]
    Analyze concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M-1 in plasma.
Not Provided
Not Provided
 
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
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

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.

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).

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Infections, Pediatrics
  • 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: 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.

  • Experimental: Ceftaroline fosamil
    Interventions:
    • Drug: Ceftaroline fosamil
    • Drug: Cephalexin or Clindamycin or Linezolid
  • Active Comparator: Comparators
    Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
    Interventions:
    • Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam
    • Drug: Cephalexin or Clindamycin or Linezolid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
270
November 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
2 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Chile,   Georgia,   Latvia,   Lithuania,   Poland,   Romania,   South Africa,   Spain
 
NCT01400867
P903-23
Yes
Cerexa, Inc.
Cerexa, Inc.
AstraZeneca
Not Provided
Cerexa, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP