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

This study has been completed.

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210899
  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. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in patients with complicated skin and skin structure infections.


Condition Intervention Phase
Skin Diseases, Infectious
Staphylococcal Skin Infections
Skin Diseases, Bacterial
Drug: ceftobiprole medocaril
Phase III

MedlinePlus related topics:   Skin Conditions   

ChemIDplus related topics:   Ceftobiprole medocaril    Cefixime   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome 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.

Secondary Outcome Measures:
  • Microbiological eradication rate at 7-14 days after the end of therapy. Clinical cure rate and microbiological relapse rate at the late follow-up visit. Safety evaluations conducted during the study.

Estimated Enrollment:   816
Study Start Date:   September 2005
Estimated Study 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).

  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 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210899

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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


Study ID Numbers:   CR005029
First Received:   September 13, 2005
Last Updated:   October 11, 2007
ClinicalTrials.gov Identifier:   NCT00210899
Health Authority:   United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Infectious Skin Diseases  
Complicated Skin Infections  
Staphylococcal Skin Infections  
Cephalosporin  
Bacterial Skin Diseases  

Study placed in the following topic categories:
Bacterial Infections
Cephalosporins
Staphylococcal Infections
Gram-Positive Bacterial Infections
Skin Diseases, Infectious
Skin Diseases
Skin Diseases, Bacterial
Cefixime
Staphylococcal Skin Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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