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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00228982
First received: September 27, 2005
Last updated: July 25, 2012
Last verified: July 2012

September 27, 2005
July 25, 2012
October 2004
December 2005   (final data collection date for primary outcome measure)
Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.
Complete list of historical versions of study NCT00228982 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Skin Diseases, Infectious
  • Skin Diseases, Bacterial
  • Staphylococcal Skin Infections
  • Drug: Ceftobiprole medocaril
  • Drug: Vancomycin
  • Experimental: Ceftobiprole medocaril
    Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d
    Intervention: Drug: Ceftobiprole medocaril
  • Active Comparator: Vancomycin
    Vancomycin 1g q12h as 1h infusion, 7-14d
    Intervention: Drug: Vancomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
784
December 2005
December 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00228982
CR005038, BAP00154
No
Basilea Pharmaceutica
Basilea Pharmaceutica
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Basilea Pharmaceutica
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP