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

May 18, 2011 updated by: Ruijin Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Linezolid alone
the control group is designed for linezolid alone treated MRSA VAP (standard treatment).
Drug: Imipenem/cilastatin
the intervention group was designed for combined linezolid plus imipenem for treating MRSA VAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRSA eradication
Time Frame: 7 th day
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.
7 th day

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 28th day
28th day
MRSA eradication
Time Frame: 14th day
14th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Pfizer

Investigators

  • Study Director: Er-Zhen Chen, M.D. & Ph.D., Emergency intensive care unit, Ruijin Hospital
  • Principal Investigator: Hong-Ping Qu, M.D., Respiratory intensive care unit, Ruijin Hospital
  • Principal Investigator: Yu-Xing Ni, M.D. & Ph.D., Microbiology laboratory, Ruijin Hospital
  • Study Chair: Zhi-Tao Yang, M.D., Emergency Department, Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (ESTIMATE)

May 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRSA-VAP YANG ZT CN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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