Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects 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, 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

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 fosamil for Injection
  • 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days
• Drug: IV Ceftriaxone
  • 1 g dose parenteral infused 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
• Drug: Clarithromycin
  • In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

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). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
• 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). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Primary Measures

• Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations
  • Time Frame: 8 to 15 days after last dose of study drug
    Safety Issue?: No
• Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (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 Test of Cure (TOC)
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No
• Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)
  • Time Frame: 8-15 days after last day of study drug
    Safety Issue?: No
• Clinical and Microbiological 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)
  • Time Frame: 21-35 days after last dose of study drug
    Safety Issue?: No
• Microbiological Re-infection/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 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 Investigator: Cerexa, Inc. Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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