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:
NCT00210899
First received: September 13, 2005
Last updated: July 25, 2012
Last verified: July 2012
  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
Skin Diseases, Bacterial
Staphylococcal Skin Infections
Drug: ceftobiprole medocaril
Drug: Vancomycin plus Ceftazidime
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:


Further study details as provided by Basilea Pharmaceutica:

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. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 828
Study Start Date: September 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vancomycin plus Ceftazidime
Vancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d
Drug: Vancomycin plus Ceftazidime
Experimental: Ceftobiprole medocaril
Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d
Drug: ceftobiprole medocaril

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT00210899     History of Changes
Other Study ID Numbers: CR005029, BAP00414
Study First Received: September 13, 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, Bacterial
Skin Diseases, Infectious
Staphylococcal Skin Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Staphylococcal Infections
Ceftazidime
Ceftobiprole
Ceftobiprole medocaril
Cephalosporins
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014