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Linezolid Alone or Combined With Carbapenem Against Methicillin-resistant Staphylococcus Aureus (MRSA) in Ventilator-associated Pneumonia

Primary Purpose

Methicillin-resistant Staphylococcus Aureus, Pneumonia, Ventilator-Associated

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Imipenem/cilastatin
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methicillin-resistant Staphylococcus Aureus focused on measuring Methicillin-resistant Staphylococcus aureus, Pneumonia, Ventilator-Associated, linezolid, imipenem/cilastatin

Eligibility Criteria

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

Inclusion Criteria:

  • Pneumonia, Ventilator-associated

    • the presence of new or persistent radiographic features
    • fever higher than 38°C
    • leukocytosis (≥11.0 ×109/L) or neutropenia (≤3.5×109/L)
    • purulent endotracheal
    • increasing oxygen requirements
  • Endotracheal aspiration culture show methicillin-resistant S. aureus positive

Exclusion Criteria:

  • immunocompromised patients (postorgan transplantation or human immunodeficiency virus-infected or neutropenic [≤1×109/L absolute neutrophils], or patients receiving corticosteroids >20 mg/d for 6 months)
  • colonized chronically with methicillin-resistant S. aureus
  • pregnancy
  • endotracheal aspiration culture showed no MRSA

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    Linezolid alone

    Arm Description

    the control group is designed for linezolid alone treated MRSA VAP (standard treatment).

    Outcomes

    Primary Outcome Measures

    MRSA eradication
    The investigators study the efficacy of Linezolid combined with Imipenem to treat the MRSA VAP, the investigators proposed the 7th day's MRSA eradication would be better than Linezolid alone.

    Secondary Outcome Measures

    MRSA eradication
    mortality

    Full Information

    First Posted
    May 17, 2011
    Last Updated
    May 18, 2011
    Sponsor
    Ruijin Hospital
    Collaborators
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01356472
    Brief Title
    Linezolid Alone or Combined With Carbapenem Against Methicillin-resistant Staphylococcus Aureus (MRSA) in Ventilator-associated Pneumonia
    Official Title
    Linezolid Alone or Combined With Carbapenem Against Methicillin-resistant Staphylococcus Aureus (MRSA) in Vitro and in Ventilator-associated Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    June 2013 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ruijin Hospital
    Collaborators
    Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    As previous studies showed that the synergy between linezolid and carbapenem in vitro and in vivo (animal studies), our study is aim to investigate the activity of linezolid, alone and in combination with carbapenem against methicillin-resistant Staphylococcus aureus (MRSA) in ventilator-associated pneumonia (VAP) patients.
    Detailed Description
    Linezolid is the only commercially available oxazolidinone, the first new class of antibiotic to be developed in the last three decades. Although it is predominantly bacteriostatic, linezolid has good in vitro and in vivo activity against MRSA . However, several studies did not show that linezolid was superior to any of glycopeptides in treatment of MRSA pneumonia. Moreover, combination therapy against MRSA is argued when several in vitro and in vivo studies showed synergy between linezolid and carbapenem or fosfomycin or rifampicin, while vancomycin and linezolid in combination should be avoided. our study is aim to investigate the activity of linezolid, alone and in combination with carbapenem against methicillin-resistant Staphylococcus aureus (MRSA) in ventilator-associated pneumonia (VAP) patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Methicillin-resistant Staphylococcus Aureus, Pneumonia, Ventilator-Associated
    Keywords
    Methicillin-resistant Staphylococcus aureus, Pneumonia, Ventilator-Associated, linezolid, imipenem/cilastatin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Linezolid alone
    Arm Type
    No Intervention
    Arm Description
    the control group is designed for linezolid alone treated MRSA VAP (standard treatment).
    Intervention Type
    Drug
    Intervention Name(s)
    Imipenem/cilastatin
    Intervention Description
    the intervention group was designed for combined linezolid plus imipenem for treating MRSA VAP
    Primary Outcome Measure Information:
    Title
    MRSA eradication
    Description
    The investigators study the efficacy of Linezolid combined with Imipenem to treat the MRSA VAP, the investigators proposed the 7th day's MRSA eradication would be better than Linezolid alone.
    Time Frame
    7 th day
    Secondary Outcome Measure Information:
    Title
    MRSA eradication
    Time Frame
    14th day
    Title
    mortality
    Time Frame
    28th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pneumonia, Ventilator-associated the presence of new or persistent radiographic features fever higher than 38°C leukocytosis (≥11.0 ×109/L) or neutropenia (≤3.5×109/L) purulent endotracheal increasing oxygen requirements Endotracheal aspiration culture show methicillin-resistant S. aureus positive Exclusion Criteria: immunocompromised patients (postorgan transplantation or human immunodeficiency virus-infected or neutropenic [≤1×109/L absolute neutrophils], or patients receiving corticosteroids >20 mg/d for 6 months) colonized chronically with methicillin-resistant S. aureus pregnancy endotracheal aspiration culture showed no MRSA
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhi-Tao Yang, M.D.
    Phone
    008613611965436
    Email
    yangzhitao@hotmail.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Er-Zhen Chen, M.D. & Ph.D.
    Organizational Affiliation
    Emergency intensive care unit, Ruijin Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hong-Ping Qu, M.D.
    Organizational Affiliation
    Respiratory intensive care unit, Ruijin Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yu-Xing Ni, M.D. & Ph.D.
    Organizational Affiliation
    Microbiology laboratory, Ruijin Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Zhi-Tao Yang, M.D.
    Organizational Affiliation
    Emergency Department, Ruijin Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15616274
    Citation
    Jacqueline C, Navas D, Batard E, Miegeville AF, Le Mabecque V, Kergueris MF, Bugnon D, Potel G, Caillon J. In vitro and in vivo synergistic activities of linezolid combined with subinhibitory concentrations of imipenem against methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2005 Jan;49(1):45-51. doi: 10.1128/AAC.49.1.45-51.2005.
    Results Reference
    background
    PubMed Identifier
    16801442
    Citation
    Jacqueline C, Caillon J, Grossi O, Le Mabecque V, Miegeville AF, Bugnon D, Batard E, Potel G. In vitro and in vivo assessment of linezolid combined with ertapenem: a highly synergistic combination against methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2006 Jul;50(7):2547-9. doi: 10.1128/AAC.01501-05.
    Results Reference
    background
    PubMed Identifier
    11170948
    Citation
    Rubinstein E, Cammarata S, Oliphant T, Wunderink R; Linezolid Nosocomial Pneumonia Study Group. Linezolid (PNU-100766) versus vancomycin in the treatment of hospitalized patients with nosocomial pneumonia: a randomized, double-blind, multicenter study. Clin Infect Dis. 2001 Feb 1;32(3):402-12. doi: 10.1086/318486. Epub 2001 Jan 26.
    Results Reference
    background
    PubMed Identifier
    16195255
    Citation
    Shorr AF, Kunkel MJ, Kollef M. Linezolid versus vancomycin for Staphylococcus aureus bacteraemia: pooled analysis of randomized studies. J Antimicrob Chemother. 2005 Nov;56(5):923-9. doi: 10.1093/jac/dki355. Epub 2005 Sep 29.
    Results Reference
    background
    PubMed Identifier
    12015695
    Citation
    Stevens DL, Herr D, Lampiris H, Hunt JL, Batts DH, Hafkin B. Linezolid versus vancomycin for the treatment of methicillin-resistant Staphylococcus aureus infections. Clin Infect Dis. 2002 Jun 1;34(11):1481-90. doi: 10.1086/340353. Epub 2002 May 13.
    Results Reference
    background

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    Linezolid Alone or Combined With Carbapenem Against Methicillin-resistant Staphylococcus Aureus (MRSA) in Ventilator-associated Pneumonia

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