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.

Condition	Intervention	Phase
Staphylococcal Skin Infections Skin Diseases, Infectious Skin Diseases, Bacterial	Drug: Ceftobiprole medocaril	Phase III

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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.
Expected Total Enrollment:  816

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).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00210899

For more information please see the link below or email       info@veritasmedicine.com

Study chairs or principal investigators

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

Study ID Numbers:  CR005029
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00210899
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27