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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Skin Diseases, Infectious
Skin Diseases, Bacterial
Staphylococcal Skin Infections
 Drug: Ceftobiprole medocaril
Drug: Vancomycin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 784
Study Start Date: October 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftobiprole medocaril
Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d
 Drug: Ceftobiprole medocaril
Active Comparator: Vancomycin
Vancomycin 1g q12h as 1h infusion, 7-14d
 Drug: Vancomycin

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228982

Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT00228982     History of Changes
Other Study ID Numbers: CR005038, BAP00154
Study First Received: September 27, 2005
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Basilea Pharmaceutica:
Complicated Skin Infections
Infectious Skin Diseases
Bacterial Skin Diseases
Staphylococcal Skin Infections
Cephalosporin

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Staphylococcal Skin Infections
Skin Diseases, Bacterial
Staphylococcal Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Vancomycin
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013