Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

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.

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 fosamil for Injection
  • 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
• Drug: Placebo
  • Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Ceftaroline fosamil for injection
  • Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
• Active Comparator: IV Ceftriaxone
  • Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).

Primary Measures

• Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No
• Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No

Secondary Measures

• Clinical Response at End of Therapy (EOT)
  • Time Frame: Last day of study drug administration
    Safety Issue?: No
• Microbiological Success Rate at TOC
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No
• Overall Clinical and Radiographic Success Rate at TOC
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No
• Clinical and Micriobiological Response by Pathogen at TOC
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No
• Clinical Relapse at Late Follow Up (LFU) Visit
  • Time Frame: 21-35 days after last dose of study drug
    Safety Issue?: No
• Microbiological Reinfection/Recurrence at LFU
  • Time Frame: 21 to 35 days after last dose of study drug
    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 Investigator: Cerexa, Inc. Industry

Overall Clinical Trial Officials and Contacts

IM Hoepelman, MD Principal Investigator UMC Utrecht  

Information obtained from ClinicalTrials.gov on February 12, 2012

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