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. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in 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: October 2006

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 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).

Interventions

  • Drug: ceftobiprole medocaril
  • Drug: Vancomycin plus Ceftazidime

Arms, Groups and Cohorts

  • Active Comparator: Vancomycin plus Ceftazidime
    • Vancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d
  • Experimental: Ceftobiprole medocaril
    • Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 7 weeks
    • 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

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 or other related anti-infective 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.

Citations Reporting on Results

Noel GJ, Bush K, Bagchi P, Ianus J, Strauss RS. A randomized, double-blind trial comparing ceftobiprole medocaril with vancomycin plus ceftazidime for the treatment of patients with complicated skin and skin-structure infections. Clin Infect Dis. 2008 Mar 1;46(5):647-55. doi: 10.1086/526527.

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