Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections - Article
Clinical Trial: Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
This study is not yet open for patient recruitment.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. September 2005
|Staphylococcal Skin Infections |
Skin Diseases, Infectious
Skin Diseases, Bacterial
| Drug: Ceftobiprole medocaril ||Phase III |
MedlinePlus related topics: Bacterial Infections; Skin Conditions; Staphylococcal Infections
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections
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).
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
Location and Contact Information
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
- Vancomycin-Intermediate/Resistant Staphylococcus aureus(VISA/VRSA) Infections (Centers for Disease Control and Prevention)