Ceftobiprole in Hospital Acquired Pneumonia

Official Title: “A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia”

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.

Ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole), referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. The patients will be randomized to receive ceftobiprole plus placebo or the comparator. The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). Patient safety will be monitored throughout the study. In December 2006, this study (BAP00307) and another similar study (BAP00248) were amended (changed) to create 1 study (BAP00248/307).Therefore, the results reported for this study will be combined with the results reported for study BAP00248. Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).

Intervention(s) in this Clinical Trial

• Drug: ceftobiprole plus placebo
  • ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days
• Drug: linezolid plus ceftazidime
  • linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 001
  • ceftobiprole plus placebo ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days
• Active Comparator: 002
  • linezolid plus ceftazidime linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days

Primary Measures

• Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)
  • Time Frame: 7 to 14 days after the end-of-therapy (EOT)
    Safety Issue?: No

Secondary Measures

• Microbiological eradication rate
  • Time Frame: At the TOC visit defined as 7-14 days after the EOT
    Safety Issue?: No
• Clinical cure rate
  • Time Frame: At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT
    Safety Issue?: No
• Microbiological eradication rates
  • Time Frame: At the LFU visit defined as 28 to 35 days after the EOT
    Safety Issue?: No
• Pneumonia-specific mortality rates
  • Time Frame: Within 30 days after randomization
    Safety Issue?: No

Inclusion Criteria:

• Patients suffering from nosocomial pneumonia or ventilator-associated pneumonia
• Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control, before entry and throughout the study, and have a negative serum or urine pregnancy test at the screening

Exclusion Criteria:

• Known or suspected hypersensitivity to any related antibiotic medications
• Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information
• Treatment with any investigational drug within 30 days before enrollment
• Prior enrollment to this study

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: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Industry

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00210964

Study ID Number: CR005032

ClinicalTrials.gov Identifier: NCT00210964

Health Authority: United States: Food and Drug Administration

Ceftobiprole in Hospital Acquired Pneumonia