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Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ceftobiprole medocaril
Ceftriaxone with or without Linezolid
Sponsored by
Basilea Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Community-Acquired Pneumonia, Cephalosporins, Methicillin-Resistant Staphylococcus Aureus

Eligibility Criteria

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

Inclusion Criteria: Patients suffering from community-acquired pneumonia severe enough to require hospitalization Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study Exclusion Criteria: Patients with known or suspected hypersensitivity to any related antibiotic medications Treatment with any experimental drug within 30 days before enrollment Prior enrollment in this study or any study with ceftobiprole medocaril

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ceftobiprole medocaril

    Ceftriaxone with or without Linezolid

    Arm Description

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

    Ceftriaxone 2g qd as 0.5h infusions with or without Linezolid 600mg q12h as 1h infusions, 7-14d

    Outcomes

    Primary Outcome Measures

    Clinical cure rate (ratio of the number of clinically cured patients to the total number of patients) at the test of cure visit that occurs 7 to 14 days after the last dose of study drug

    Secondary Outcome Measures

    Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients)

    Full Information

    First Posted
    May 12, 2006
    Last Updated
    July 25, 2012
    Sponsor
    Basilea Pharmaceutica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00326287
    Brief Title
    Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia
    Official Title
    A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 2007 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the clinical cure rate (ratio of clinically cured patients to the total number of patients) of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia.
    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 community-acquired pneumonia. 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 community-acquired pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. Patients who meet specified criteria may be switched to an alternative oral treatment. The primary endpoint is that the clinical cure rate among patients treated with ceftobiprole at the test of cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia
    Keywords
    Community-Acquired Pneumonia, Cephalosporins, Methicillin-Resistant Staphylococcus Aureus

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Ceftobiprole medocaril
    Arm Type
    Experimental
    Arm Description
    Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d
    Arm Title
    Ceftriaxone with or without Linezolid
    Arm Type
    Active Comparator
    Arm Description
    Ceftriaxone 2g qd as 0.5h infusions with or without Linezolid 600mg q12h as 1h infusions, 7-14d
    Intervention Type
    Drug
    Intervention Name(s)
    Ceftobiprole medocaril
    Intervention Type
    Drug
    Intervention Name(s)
    Ceftriaxone with or without Linezolid
    Primary Outcome Measure Information:
    Title
    Clinical cure rate (ratio of the number of clinically cured patients to the total number of patients) at the test of cure visit that occurs 7 to 14 days after the last dose of study drug
    Time Frame
    7 weeks
    Secondary Outcome Measure Information:
    Title
    Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients)
    Time Frame
    7 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients suffering from community-acquired pneumonia severe enough to require hospitalization Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study Exclusion Criteria: Patients with known or suspected hypersensitivity to any related antibiotic medications Treatment with any experimental drug within 30 days before enrollment Prior enrollment in this study or any study with ceftobiprole medocaril
    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
    34155899
    Citation
    Huang H, Gao L, Engelhardt M, Saulay M, Hamed K. A post hoc analysis of two Phase III trials showing the efficacy and tolerability of ceftobiprole in East Asian patients. Future Microbiol. 2021 Jul;16:783-796. doi: 10.2217/fmb-2021-0121. Epub 2021 Jun 22.
    Results Reference
    derived
    PubMed Identifier
    33960817
    Citation
    Welte T, Scheeren TW, Overcash JS, Saulay M, Engelhardt M, Hamed K. Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies. Future Microbiol. 2021 May;16:543-555. doi: 10.2217/fmb-2021-0042. Epub 2021 May 7.
    Results Reference
    derived
    PubMed Identifier
    30808293
    Citation
    Scheeren TWL, Welte T, Saulay M, Engelhardt M, Santerre-Henriksen A, Hamed K. Early improvement in severely ill patients with pneumonia treated with ceftobiprole: a retrospective analysis of two major trials. BMC Infect Dis. 2019 Feb 26;19(1):195. doi: 10.1186/s12879-019-3820-y.
    Results Reference
    derived
    PubMed Identifier
    22230331
    Citation
    Nicholson SC, Welte T, File TM Jr, Strauss RS, Michiels B, Kaul P, Balis D, Arbit D, Amsler K, Noel GJ. A randomised, double-blind trial comparing ceftobiprole medocaril with ceftriaxone with or without linezolid for the treatment of patients with community-acquired pneumonia requiring hospitalisation. Int J Antimicrob Agents. 2012 Mar;39(3):240-6. doi: 10.1016/j.ijantimicag.2011.11.005. Epub 2012 Jan 9.
    Results Reference
    derived
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=731&filename=CR011407_CSR.pdf.pdf
    Description
    Ceftobiprole in the Treatment of Patients with Community-Acquired Pneumonia

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