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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

Page last updated: August 23, 2015

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