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

NCT ID: NCT01356472

Last Updated: 2011-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Methicillin-resistant Staphylococcus Aureus Pneumonia, Ventilator-Associated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Linezolid alone

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

Group Type NO_INTERVENTION

Imipenem/cilastatin

Intervention Type DRUG

the intervention group was designed for combined linezolid plus imipenem for treating MRSA VAP

Interventions

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Imipenem/cilastatin

the intervention group was designed for combined linezolid plus imipenem for treating MRSA VAP

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emergency Department, Ruijin Hospital

Principal Investigators

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Er-Zhen Chen, M.D. & Ph.D.

Role: STUDY_DIRECTOR

Emergency intensive care unit, Ruijin Hospital

Hong-Ping Qu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Respiratory intensive care unit, Ruijin Hospital

Yu-Xing Ni, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Microbiology laboratory, Ruijin Hospital

Zhi-Tao Yang, M.D.

Role: STUDY_CHAIR

Emergency Department, Ruijin Hospital

Central Contacts

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Zhi-Tao Yang, M.D.

Role: CONTACT

008613611965436

References

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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.

Reference Type BACKGROUND
PMID: 15616274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16801442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11170948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16195255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12015695 (View on PubMed)

Other Identifiers

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MRSA-VAP YANG ZT CN

Identifier Type: -

Identifier Source: org_study_id

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