Official Title: “A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections”

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in patients with complicated skin and skin structure infections.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, 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 complicated skin and skin structure infections. 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 complicated skin and skin structure infections. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The patients can be treated as in-patient, out-patient, or through a home agency, at the discretion of the investigator. 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) 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 rate at the late follow-up visit. Safety evaluations conducted during the study.

Inclusion Criteria:

• Diagnosis of an infection consistent with complicated skin and skin structure infections

Exclusion Criteria:

• Known or suspected hypersensitivity to any study medication or other related anti-infective medication
• Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
• Previous enrollment in this study
• Treatment with any investigational drug within 30 days before enrollment

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 December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00210899

Study ID Number: CR005029

ClinicalTrials.gov Identifier: NCT00210899

Health Authority: United States: Food and Drug Administration