Official Title: “A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Nosocomial Pneumonia”

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with nosocomial pneumonia.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with nosocomial pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit.

The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).

Intervention(s) in this Clinical Trial

• Drug: ceftobiprole medocaril

Primary Measures

• Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) measured at 7-14 days after the end of therapy.

Secondary Measures

• Microbiological eradication rate at 7-14 days after the end of therapy. Clinical cure rate and microbiological relapse at the late follow-up visit. All deaths due to pneumonia within 30 days after the randomization.

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

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00229008

Study ID Number: CR005140

ClinicalTrials.gov Identifier: NCT00229008

Health Authority: United States: Food and Drug Administration