Official Title: “A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia”

The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Intervention(s) in this Clinical Trial

• Drug: ceftaroline
  • 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days
• Drug: ceftriaxone
  • 1 g dose parenteral infused over 30 minutes over 30 minutes, every 24 hours for 5 to 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• Determine the non-inferiority in the overall success rate for ceftaroline compared to that for ceftriaxone
  • Time Frame: Test-of-Cure (TOC) visit
    Safety Issue?: No

Secondary Measures

• Evaluate the clinical response
  • Time Frame: End-of-Therapy (EOT) and TOC visits
    Safety Issue?: No
• Evaluate the microbiological success rate
  • Time Frame: TOC visit
    Safety Issue?: No
• Evaluate the clinical and microbiological response
  • Time Frame: TOC visit
    Safety Issue?: No
• Evaluate clinical relapse
  • Time Frame: Late Follow-up (LFU) visit
    Safety Issue?: No
• Evaluate microbiological reinfection/recurrence
  • Time Frame: LFU visit
    Safety Issue?: No
• Evaluate safety
  • Time Frame: first dose, throughout the treatment period, and up to the TOC visit
    Safety Issue?: Yes

Inclusion Criteria:

Subjects with community-acquired pneumonia requiring:

• initial hospitalization or treatment in an emergency room or urgent care setting
• infection requiring initial treatment with IV antimicrobial

Exclusion Criteria:

• Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent
• Respiratory tract infections not due to community-acquired bacterial pathogens
• Infections resistant to ceftriaxone
• Any condition requiring concomitant systemic corticosteroids
• History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cerexa, Inc.

Overall Clinical Trial Officials and Contacts

IM Hoepelman, MD Principal Investigator University Medical Center Utrecht  

Overall Contact: Trial Coordinator  clinicaltrials@cerexa.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00509106

Study ID Number: P903-09

ClinicalTrials.gov Identifier: NCT00509106

Health Authority: United States: Food and Drug Administration