Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections

Overview

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.

Full Title of Study: “A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2005

Detailed Description

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).

Interventions

  • Drug: Ceftobiprole medocaril
  • Drug: Vancomycin

Arms, Groups and Cohorts

  • Experimental: Ceftobiprole medocaril
    • Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d
  • Active Comparator: Vancomycin
    • Vancomycin 1g q12h as 1h infusion, 7-14d

Clinical Trial Outcome Measures

Primary Measures

  • Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.
    • Time Frame: 7 weeks

Secondary Measures

  • 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.
    • Time Frame: 7 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of an infection consistent with complicated skin and skin structure infections. Exclusion Criteria:

  • Known or suspected hypersensitivity to any study 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Basilea Pharmaceutica
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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