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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: | NCT00228982 |
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.
Condition | Intervention | Phase |
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Staphylococcal Skin Infections Skin Diseases, Infectious 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: | 790 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | November 2005 |
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 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: | CR005038 |
Study First Received: | September 27, 2005 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00228982 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Complicated Skin Infections Cephalosporin Staphylococcal Skin Infections Infectious Skin Diseases Bacterial Skin Diseases |
Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Cephalosporins Staphylococcal Infections Gram-Positive Bacterial Infections |
Skin Diseases, Infectious Skin Diseases Skin Diseases, Bacterial Cefixime Staphylococcal Skin Infections |
Bacterial Infections Communicable Diseases Cephalosporins Anti-Infective Agents Skin Diseases Staphylococcal Skin Infections Infection |
Pharmacologic Actions Staphylococcal Infections Anti-Bacterial Agents Skin Diseases, Infectious Gram-Positive Bacterial Infections Skin Diseases, Bacterial Therapeutic Uses |