A Phase 3 interventional study of ceftobiprole medocaril and Vancomycin plus Ceftazidime in Skin Diseases, Infectious, Skin Diseases, Bacterial and Staphylococcal Skin Infections, sponsored by Basilea Pharmaceutica. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-26.
Sponsored by Basilea Pharmaceutica · Phase 3, Interventional, and Treatment
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.
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).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 828 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Vancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d
Drug: Vancomycin plus Ceftazidime
Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d
Drug: ceftobiprole medocaril
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.
7-14 days treatment, test of cure assessment at 7-14 days after end of treatment, late follow-up 28-35 days after end of treatment
Time frame: 7 weeks
No study locations are listed for this record.
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Basilea Pharmaceutica