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

Primary Purpose

Skin Diseases, Infectious, Skin Diseases, Bacterial, Staphylococcal Skin Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ceftobiprole medocaril
Vancomycin plus Ceftazidime
Sponsored by
Basilea Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases, Infectious focused on measuring Complicated Skin Infections, Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections, Cephalosporin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Vancomycin plus Ceftazidime

    Ceftobiprole medocaril

    Arm Description

    Vancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d

    Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d

    Outcomes

    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.
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    July 25, 2012
    Sponsor
    Basilea Pharmaceutica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00210899
    Brief Title
    Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
    Official Title
    A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Basilea Pharmaceutica

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Diseases, Infectious, Skin Diseases, Bacterial, Staphylococcal Skin Infections
    Keywords
    Complicated Skin Infections, Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections, Cephalosporin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    828 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vancomycin plus Ceftazidime
    Arm Type
    Active Comparator
    Arm Description
    Vancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d
    Arm Title
    Ceftobiprole medocaril
    Arm Type
    Experimental
    Arm Description
    Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d
    Intervention Type
    Drug
    Intervention Name(s)
    ceftobiprole medocaril
    Intervention Type
    Drug
    Intervention Name(s)
    Vancomycin plus Ceftazidime
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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
    Time Frame
    7 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18225981
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=630&filename=CR005029_CSR.pdf
    Description
    Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections

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