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

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

Study Type: Interventional

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

Study Primary Completion Date: February 2009

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

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, 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 of ceftaroline compared to that for ceftriaxone in adult subjects with community-acquired pneumonia (CAP)
  • Time Frame: Test-of-Cure (TOC)
    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 by pathogen
  • Time Frame: TOC visit
    Safety Issue?: No
• Evaluate clinical relapse
  • Time Frame: Late Follow-up (LFU) visit
    Safety Issue?: No
• Evaluate microbiological re-infection/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 are required to meet the following inclusion criteria:

• Community-acquired pneumonia
• initial hospitalization, or treatment in an emergency room or urgent care setting
• infection would require initial treatment with IV antimicrobials.

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

• CAP suitable for outpatient therapy with an oral antimicrobial agent
• respiratory tract infections not due to community-acquired bacterial
• Non-infectious causes of pulmonary infiltrates
• Pleural empyema
• Infection with an atypical organism
• History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
• History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide

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

Thomas M File, MD, MS Study Director Summa Health System  

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/NCT00621504

Study ID Number: P903-08

ClinicalTrials.gov Identifier: NCT00621504

Health Authority: United States: Food and Drug Administration