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Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01669980
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : November 1, 2015
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Description
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Brief Summary:
This is a study of safety and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.

Condition or disease Intervention/treatment Phase
Infections Pneumonia Drug: Ceftaroline fosamil Drug: IV Ceftriaxone and Vancomycin Phase 4

Detailed Description:
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to < 18 years who are initially hospitalized with Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ceftaroline fosamil Drug: Ceftaroline fosamil
  • Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour)
  • Subjects < 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour)

Optional Oral Switch:

  • PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
  • PO clindamycin 13 mg/kg/dose
  • PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
Other Names:
  • Teflaro
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
Active Comparator: IV Ceftriaxone and Vancomycin Drug: IV Ceftriaxone and Vancomycin
  • IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND
  • IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes.

Optional Oral Switch:

  • PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
  • PO clindamycin 13 mg/kg/dose
  • PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the safety and tolerability of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects ages 2 months to < 18 years with complicated community-acquired bacterial pneumonia (CABP) [ Time Frame: between 1 and 57 days ]
    Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with complicated CABP. Summaries of patient AEs, SAEs, deaths, discontinuations due to AEs, laboratory evaluations (hematology studies, comprehensive and metabolic panel), and vital signs will be provided for each treatment group.


Secondary Outcome Measures :
  1. To evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA). [ Time Frame: between 4 and 57 days ]
    Evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA) by assessing clinical stability of the subject at study day 4 and clinical outcome at End of IV, End of Treatment and Test of Cure.

  2. Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA) [ Time Frame: between 4 and 57 days ]
    Analyze concentrations of ceftaroline, ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) in plasma, and, if available, in cerebrospinal fluid (CSF, if collected as part of standard of care)


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of CABP warranting 3 days of initial hospitalization
  • Confirmed presence of indicators of complicated CABP

Exclusion Criteria:

  • Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial
  • Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism
  • Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia
  • Non-infectious causes of pulmonary infiltrates
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669980


Locations
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United States, California
Investigational Site
Long Beach, California, United States
Oakland, California, United States
Investigational Site
Orange County, California, United States
Investigational Site
San Diego, California, United States
United States, Massachusetts
Investigational Site
Boston, Massachusetts, United States
United States, Ohio
Investigational Site
Cleveland, Ohio, United States
Investigational Site
Toledo, Ohio, United States
United States, Pennsylvania
Investigational Site
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Investigational Site
Memphis, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Investigational Site
Norfolk, Virginia, United States
United States, West Virginia
Investigational Site
Morgantown, West Virginia, United States
Argentina
Investigative Site
Buenos Aires, Argentina
Georgia
Investigational Site 1
Tbilisi, Georgia
Investigational Site 2
Tbilisi, Georgia
Investigational Site 3
Tbilisi, Georgia
Ukraine
Investigational Site
Donetsk, Ukraine
Investigational Site
Ivano-Frankivsk, Ukraine
Investigational Site
Kryvyi Rih, Ukraine
Investigational Site
Kyiv, Ukraine
Sponsors and Collaborators
Forest Laboratories
More Information
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01669980    
Other Study ID Numbers: P903-24
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: November 1, 2015
Last Verified: October 2015
Keywords provided by Forest Laboratories:
Infections
Pediatrics
Teflaro
Ceftriaxone
cephalosporin
Vancomycin
 Clindamycin
Amoxicillin Clavulanate
Linezolid
MRSA
pneumonia
Additional relevant MeSH terms:
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Pneumonia
Infections
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
 Vancomycin
Ceftriaxone
Ceftaroline fosamil
Anti-Bacterial Agents
Anti-Infective Agents