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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01669980
First received: August 17, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Infections
Pneumonia
Drug: Ceftaroline fosamil
Drug: IV Ceftriaxone and Vancomycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: October 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: 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

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)

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669980

Locations
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
Cerexa, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT01669980     History of Changes
Other Study ID Numbers: P903-24
Study First Received: August 17, 2012
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Romania: National Agency for Medicines and Medical Devices
Romania: Ethics Committee
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Cerexa, Inc.:
Infections
Pediatrics
Teflaro
Ceftriaxone
cephalosporin
Vancomycin
Clindamycin
Amoxicillin Clavulanate
Linezolid
MRSA
pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Ceftriaxone
Clindamycin
Vancomycin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
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 August 27, 2014