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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00210899 |
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 |
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Skin Diseases, Infectious Staphylococcal Skin Infections Skin Diseases, Bacterial |
Drug: ceftobiprole medocaril |
Phase III |
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 |
Estimated Enrollment: | 816 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | October 2006 |
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR005029 |
Study First Received: | September 13, 2005 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00210899 |
Health Authority: | United States: Food and Drug Administration |
Infectious Skin Diseases Complicated Skin Infections Staphylococcal Skin Infections Cephalosporin Bacterial Skin Diseases |
Bacterial Infections Cephalosporins Staphylococcal Infections Gram-Positive Bacterial Infections Skin Diseases, Infectious |
Skin Diseases Skin Diseases, Bacterial Cefixime Staphylococcal Skin Infections |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases |
Therapeutic Uses Infection Pharmacologic Actions |