Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)
Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections; Pneumonia
Intervention: Ceftaroline fosamil (Drug); IV Ceftriaxone and Vancomycin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Forest Laboratories
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: 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).Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
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
Minimum age: 2 Months.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Investigative Site, Buenos Aires, Argentina
Investigational Site 1, Tbilisi, Georgia
Investigational Site 2, Tbilisi, Georgia
Investigational Site 3, Tbilisi, Georgia
Investigational Site, Donetsk, Ukraine
Investigational Site, Ivano-Frankivsk, Ukraine
Investigational Site, Kryvyi Rih, Ukraine
Investigational Site, Kyiv, Ukraine
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
Investigational Site, Boston, Massachusetts, United States
Investigational Site, Cleveland, Ohio, United States
Investigational Site, Toledo, Ohio, United States
Investigational Site, Pittsburgh, Pennsylvania, United States
Investigational Site, Memphis, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Investigational Site, Norfolk, Virginia, United States
Investigational Site, Morgantown, West Virginia, United States
Additional Information
Sponsor Homepage
Starting date: October 2012
Last updated: January 12, 2015
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