Trial record 1 of 142 for:    "Pneumonia, Ventilator-Associated"
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Linezolid Alone or Combined With Carbapenem Against Methicillin-resistant Staphylococcus Aureus (MRSA) in Ventilator-associated Pneumonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Ruijin Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01356472
First received: May 17, 2011
Last updated: May 18, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Methicillin-resistant Staphylococcus Aureus
Pneumonia, Ventilator-Associated
Drug: Imipenem/cilastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Linezolid Alone or Combined With Carbapenem Against Methicillin-resistant Staphylococcus Aureus (MRSA) in Vitro and in Ventilator-associated Pneumonia

Resource links provided by NLM:


Further study details as provided by Ruijin Hospital:

Primary Outcome Measures:
  • MRSA eradication [ Time Frame: 7 th day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14th day ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: 28th day ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356472

Contacts
Contact: Zhi-Tao Yang, M.D. 008613611965436 yangzhitao@hotmail.fr

Sponsors and Collaborators
Ruijin Hospital
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
  More Information

Publications:
Responsible Party: YANG Zhi-Tao, Emergency Department, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01356472     History of Changes
Other Study ID Numbers: MRSA-VAP YANG ZT CN
Study First Received: May 17, 2011
Last Updated: May 18, 2011
Health Authority: China: Ethics Committee
China: Ministry of Health

Keywords provided by Ruijin Hospital:
Methicillin-resistant Staphylococcus aureus
Pneumonia, Ventilator-Associated
linezolid
imipenem/cilastatin

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Pneumonia
Staphylococcal Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Cilastatin
Linezolid
Imipenem
Methicillin
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014