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

NCT01400867 | Completed Phase 2 DMC

• 1 other identifier: P903-23
• Study Type: interventional
• Target: 163
• Locations: 10 countries
• Sites: 71

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.

Conditions

Infections, Pediatrics

Keywords

Infections; Pediatrics; Teflaro; cephalosporin

Outcome Measures

Primary Outcomes (1)

• 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.

  Between 26 and 50 days.

Secondary Outcomes (2)

• Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.

  Between 1 and 5 days

• Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.

  Between 1 and 5 days

Study Arms (2)

Ceftaroline fosamil

EXPERIMENTAL

Drug: Ceftaroline fosamil; Drug: Cephalexin or Clindamycin or Linezolid

Comparators

ACTIVE COMPARATOR

Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam

Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam; Drug: Cephalexin or Clindamycin or Linezolid

Interventions

Ceftaroline fosamil DRUG

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)

Also known as: Teflaro, PPI-0903, TAK-599, TAK599, PPI0903

Ceftaroline fosamil

Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam DRUG

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

Comparators

Cephalexin or Clindamycin or Linezolid DRUG

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.

Ceftaroline fosamil; Comparators

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead
• AstraZeneca: collaborator

Study Sites (71)

Investigational Site - Phoenix

Phoenix, Arizona, United States

Location

Investigational Site - Orange

Orange, California, United States

Location

Investigational Site - San Diego

San Diego, California, United States

Location

Investigational Site - Jacksonville

Jacksonville, Florida, United States

Location

Investigational Site - Atlanta

Atlanta, Georgia, United States

Location

Investigational Site - Chicago 1

Chicago, Illinois, United States

Location

Investigational Site - Chicago 2

Chicago, Illinois, United States

Location

Investigational Site - Springfield

Springfield, Illinois, United States

Location

Investigational Site - Shreveport

Shreveport, Louisiana, United States

Location

Investigational Site - Baltimore

Baltimore, Maryland, United States

Location

Investigational Site - Detroit

Detroit, Michigan, United States

Location

Investigational Site - Brooklyn

Brooklyn, New York, United States

Location

Investigational Site - New Hyde Park

New Hyde Park, New York, United States

Location

Investigational Site - Rochester

Rochester, New York, United States

Location

Investigational Site - Bronx

The Bronx, New York, United States

Location

Investigational Site - Akron

Akron, Ohio, United States

Location

Investigational Site - Cleveland 1

Cleveland, Ohio, United States

Location

Investigational Site - Cleveland 2

Cleveland, Ohio, United States

Location

Investigational Site - Toledo

Toledo, Ohio, United States

Location

Investigational Site - Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Investigational Site - Charleston

Charleston, South Carolina, United States

Location

Investigational Site - Memphis

Memphis, Tennessee, United States

Location

Investigational Site - Austin 1

Austin, Texas, United States

Location

Investigational Site - Fort Worth

Fort Worth, Texas, United States

Location

Investigational Site - Norfolk

Norfolk, Virginia, United States

Location

Investigational Site - Richmond

Richmond, Virginia, United States

Location

Investigational Site - Seattle

Seattle, Washington, United States

Location

Investigational Site - Morgantown

Morgantown, West Virginia, United States

Location

Investigational Site - Buenos Aires 1

Buenos Aires, Argentina

Location

Investigational Site - Buenos Aires 2

Buenos Aires, Argentina

Location

Investigational Site - Buenos Aires 3

Buenos Aires, Argentina

Location

Investigational Site - Buenos Aires 4

Buenos Aires, Argentina

Location

Investigational Site - Buenos Aires 5

Buenos Aires, Argentina

Location

Investigational Site - Buenos Aires 6

Buenos Aires, Argentina

Location

Investigational Site - Santa Fe 1

Santa Fe, Argentina

Location

Investigational Site - Santa Fe 2

Santa Fe, Argentina

Location

Investigational Site - Puente Alto

Puente Alto, Santiago Metropolitan, Chile

Location

Investigational Site - San Ramon

San Ramón, Santiago Metropolitan, Chile

Location

Investigational Site - Vitacura

Vitacura, Santiago Metropolitan, Chile

Location

Investigational Site - Vina Del Mar

Viña del Mar, Chile

Location

Investigational Site - Tbilisi 1

Tbilisi, Georgia

Location

Investigational Site - Tbilisi 2

Tbilisi, Georgia

Location

Investigational Site - Daugavpils

Daugavpils, Latvia

Location

Investigational Site - Liepaja

Liepāja, Latvia

Location

Investigational Site - Rezekne

Rēzekne, Latvia

Location

Investigational Site - Riga

Riga, Latvia

Location

Investigational Site - Kaunas

Kaunas, Lithuania

Location

Investigational Site - Vilnius

Vilnius, Lithuania

Location

Investigational Site - Bydgoszcz 1

Bydgoszcz, Poland

Location

Investigational Site - Bydgoszcz 2

Bydgoszcz, Poland

Location

Investigational Site - Lodz

Lodz, Poland

Location

Investigational Site - Lublin

Lublin, Poland

Location

Investigational Site - Rzeszow

Rzeszów, Poland

Location

Investigational Site - Warszawa

Warsaw, Poland

Location

Investigational Site - Bucharest 1

Bucharest, Romania

Location

Investigational Site - Bucharest 2

Bucharest, Romania

Location

Investigational Site - Constanta

Constanța, Romania

Location

Investigational Site - Tirgu Mures

Târgu Mureş, Romania

Location

Investigational Site - Timisoara

Timișoara, Romania

Location

Investigational Site - Cape Town 1

Cape Town, South Africa

Location

Investigational Site - Cape Town 2

Cape Town, South Africa

Location

Investigational Site - Cape Town 3

Cape Town, South Africa

Location

Investigational Site - Johannesburg

Johannesburg, South Africa

Location

Investigational Site - Badalona

Badalona, Spain

Location

Investigational Site - Esplugues de Llobregat

Esplugues de Llobregat, Spain

Location

Investigational Site - Getafe

Getafe, Spain

Location

Investigational Site - Madrid 1

Madrid, Spain

Location

Investigational Site - Madrid 2

Madrid, Spain

Location

Investigational Site - Madrid 3

Madrid, Spain

Location

Investigational Site - Santiago de Compostela

Santiago de Compostela, Spain

Location

Investigational Site - Valencia

Valencia, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Infections

Interventions

Ceftaroline; Cephalexin; Clindamycin; Linezolid

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Acetamides; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 22, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

LA (4); LI (2); RO (5); PL (6); AR (8); US (28); ZA (4); ES (8); CL (4); GE (2)