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| ID | Type | Description | Link |
|---|---|---|---|
| BAP00154 | Other Identifier | Basilea Pharmaceutica International Ltd. |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftobiprole medocaril | Experimental | Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d |
|
| Vancomycin | Active Comparator | Vancomycin 1g q12h as 1h infusion, 7-14d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftobiprole medocaril | Drug |
| ||
| Vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological outcome at 7-14 days after the end of therapy. Clinical and microbiological outcome at late follow-up visit. Evolution of signs and symptoms of disease. Time to clinical cure. Safety and tolerability evaluations during the study. | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D017192 | Skin Diseases, Bacterial |
| D013207 | Staphylococcal Skin Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C505439 | ceftobiprole medocaril |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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|
| D001423 |
| Bacterial Infections and Mycoses |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D000602 |
| Amino Acids, Peptides, and Proteins |