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

Primary Purpose

Infections, Pediatrics

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ceftaroline fosamil
Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam
Cephalexin or Clindamycin or Linezolid
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Pediatrics focused on measuring Infections, Pediatrics, Teflaro, cephalosporin

Eligibility Criteria

2 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site - Phoenix
  • Investigational Site - Orange
  • Investigational Site - San Diego
  • Investigational Site - Jacksonville
  • Investigational Site - Atlanta
  • Investigational Site - Chicago 1
  • Investigational Site - Chicago 2
  • Investigational Site - Springfield
  • Investigational Site - Shreveport
  • Investigational Site - Baltimore
  • Investigational Site - Detroit
  • Investigational Site - Bronx
  • Investigational Site - Brooklyn
  • Investigational Site - New Hyde Park
  • Investigational Site - Rochester
  • Investigational Site - Akron
  • Investigational Site - Cleveland 1
  • Investigational Site - Cleveland 2
  • Investigational Site - Toledo
  • Investigational Site - Pittsburgh
  • Investigational Site - Charleston
  • Investigational Site - Memphis
  • Investigational Site - Austin 1
  • Investigational Site - Fort Worth
  • Investigational Site - Norfolk
  • Investigational Site - Richmond
  • Investigational Site - Seattle
  • Investigational Site - Morgantown
  • Investigational Site - Buenos Aires 1
  • Investigational Site - Buenos Aires 2
  • Investigational Site - Buenos Aires 3
  • Investigational Site - Buenos Aires 4
  • Investigational Site - Buenos Aires 5
  • Investigational Site - Buenos Aires 6
  • Investigational Site - Santa Fe 1
  • Investigational Site - Santa Fe 2
  • Investigational Site - Puente Alto
  • Investigational Site - San Ramon
  • Investigational Site - Vitacura
  • Investigational Site - Vina Del Mar
  • Investigational Site - Tbilisi 1
  • Investigational Site - Tbilisi 2
  • Investigational Site - Daugavpils
  • Investigational Site - Liepaja
  • Investigational Site - Rezekne
  • Investigational Site - Riga
  • Investigational Site - Kaunas
  • Investigational Site - Vilnius
  • Investigational Site - Bydgoszcz 1
  • Investigational Site - Bydgoszcz 2
  • Investigational Site - Lodz
  • Investigational Site - Lublin
  • Investigational Site - Rzeszow
  • Investigational Site - Warszawa
  • Investigational Site - Bucharest 1
  • Investigational Site - Bucharest 2
  • Investigational Site - Constanta
  • Investigational Site - Timisoara
  • Investigational Site - Tirgu Mures
  • Investigational Site - Cape Town 1
  • Investigational Site - Cape Town 2
  • Investigational Site - Cape Town 3
  • Investigational Site - Johannesburg
  • Investigational Site - Badalona
  • Investigational Site - Esplugues de Llobregat
  • Investigational Site - Getafe
  • Investigational Site - Madrid 1
  • Investigational Site - Madrid 2
  • Investigational Site - Madrid 3
  • Investigational Site - Santiago de Compostela
  • Investigational Site - Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftaroline fosamil

Comparators

Arm Description

Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam

Outcomes

Primary Outcome Measures

Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
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.
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.
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)

Full Information

First Posted
July 19, 2011
Last Updated
January 12, 2015
Sponsor
Forest Laboratories
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01400867
Brief Title
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Pediatrics
Keywords
Infections, Pediatrics, Teflaro, cephalosporin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftaroline fosamil
Arm Type
Experimental
Arm Title
Comparators
Arm Type
Active Comparator
Arm Description
Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
Intervention Type
Drug
Intervention Name(s)
Ceftaroline fosamil
Other Intervention Name(s)
Teflaro, PPI-0903, TAK-599, TAK599, PPI0903
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cephalexin or Clindamycin or Linezolid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Description
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.
Time Frame
Between 26 and 50 days.
Secondary Outcome Measure Information:
Title
Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Description
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.
Time Frame
Between 1 and 5 days
Title
Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Description
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)
Time Frame
Between 1 and 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigational Site - Phoenix
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Investigational Site - Orange
City
Orange
State/Province
California
Country
United States
Facility Name
Investigational Site - San Diego
City
San Diego
State/Province
California
Country
United States
Facility Name
Investigational Site - Jacksonville
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Investigational Site - Atlanta
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Investigational Site - Chicago 1
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Investigational Site - Chicago 2
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Investigational Site - Springfield
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Investigational Site - Shreveport
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Investigational Site - Baltimore
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Investigational Site - Detroit
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Investigational Site - Bronx
City
Bronx
State/Province
New York
Country
United States
Facility Name
Investigational Site - Brooklyn
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Investigational Site - New Hyde Park
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
Investigational Site - Rochester
City
Rochester
State/Province
New York
Country
United States
Facility Name
Investigational Site - Akron
City
Akron
State/Province
Ohio
Country
United States
Facility Name
Investigational Site - Cleveland 1
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Investigational Site - Cleveland 2
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Investigational Site - Toledo
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Investigational Site - Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Investigational Site - Charleston
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Investigational Site - Memphis
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Investigational Site - Austin 1
City
Austin
State/Province
Texas
Country
United States
Facility Name
Investigational Site - Fort Worth
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Investigational Site - Norfolk
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Investigational Site - Richmond
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Investigational Site - Seattle
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Investigational Site - Morgantown
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Investigational Site - Buenos Aires 1
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site - Buenos Aires 2
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site - Buenos Aires 3
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site - Buenos Aires 4
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site - Buenos Aires 5
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site - Buenos Aires 6
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site - Santa Fe 1
City
Santa Fe
Country
Argentina
Facility Name
Investigational Site - Santa Fe 2
City
Santa Fe
Country
Argentina
Facility Name
Investigational Site - Puente Alto
City
Puente Alto
State/Province
Santiago
Country
Chile
Facility Name
Investigational Site - San Ramon
City
San Ramon
State/Province
Santiago
Country
Chile
Facility Name
Investigational Site - Vitacura
City
Vitacura
State/Province
Santiago
Country
Chile
Facility Name
Investigational Site - Vina Del Mar
City
Vina del Mar
Country
Chile
Facility Name
Investigational Site - Tbilisi 1
City
Tbilisi
Country
Georgia
Facility Name
Investigational Site - Tbilisi 2
City
Tbilisi
Country
Georgia
Facility Name
Investigational Site - Daugavpils
City
Daugavpils
Country
Latvia
Facility Name
Investigational Site - Liepaja
City
Liepaja
Country
Latvia
Facility Name
Investigational Site - Rezekne
City
Rezekne
Country
Latvia
Facility Name
Investigational Site - Riga
City
Riga
Country
Latvia
Facility Name
Investigational Site - Kaunas
City
Kaunas
Country
Lithuania
Facility Name
Investigational Site - Vilnius
City
Vilnius
Country
Lithuania
Facility Name
Investigational Site - Bydgoszcz 1
City
Bydgoszcz
Country
Poland
Facility Name
Investigational Site - Bydgoszcz 2
City
Bydgoszcz
Country
Poland
Facility Name
Investigational Site - Lodz
City
Lodz
Country
Poland
Facility Name
Investigational Site - Lublin
City
Lublin
Country
Poland
Facility Name
Investigational Site - Rzeszow
City
Rzeszow
Country
Poland
Facility Name
Investigational Site - Warszawa
City
Warszawa
Country
Poland
Facility Name
Investigational Site - Bucharest 1
City
Bucharest
Country
Romania
Facility Name
Investigational Site - Bucharest 2
City
Bucharest
Country
Romania
Facility Name
Investigational Site - Constanta
City
Constanta
Country
Romania
Facility Name
Investigational Site - Timisoara
City
Timisoara
Country
Romania
Facility Name
Investigational Site - Tirgu Mures
City
Tirgu Mures
Country
Romania
Facility Name
Investigational Site - Cape Town 1
City
Cape Town
Country
South Africa
Facility Name
Investigational Site - Cape Town 2
City
Cape Town
Country
South Africa
Facility Name
Investigational Site - Cape Town 3
City
Cape Town
Country
South Africa
Facility Name
Investigational Site - Johannesburg
City
Johannesburg
Country
South Africa
Facility Name
Investigational Site - Badalona
City
Badalona
Country
Spain
Facility Name
Investigational Site - Esplugues de Llobregat
City
Esplugues de Llobregat
Country
Spain
Facility Name
Investigational Site - Getafe
City
Getafe
Country
Spain
Facility Name
Investigational Site - Madrid 1
City
Madrid
Country
Spain
Facility Name
Investigational Site - Madrid 2
City
Madrid
Country
Spain
Facility Name
Investigational Site - Madrid 3
City
Madrid
Country
Spain
Facility Name
Investigational Site - Santiago de Compostela
City
Santiago de Compostela
Country
Spain
Facility Name
Investigational Site - Valencia
City
Valencia
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.cerexa.com
Description
Related Info

Learn more about this trial

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

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