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Status unknownNCT01356472Updated May 19, 2011

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

A Phase 4 interventional study of Imipenem/cilastatin in Methicillin-resistant Staphylococcus Aureus and Pneumonia, Ventilator-Associated, sponsored by Ruijin Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-19.

Sponsored by Ruijin Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Methicillin-resistant Staphylococcus Aureus
  • Pneumonia, Ventilator-Associated

Keywords

  • Methicillin-resistant Staphylococcus aureus
  • Pneumonia, Ventilator-Associated
  • linezolid
  • imipenem/cilastatin
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 60 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • No intervention
    Linezolid alone

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

    Drug: Imipenem/cilastatin

Interventions

  • DrugImipenem/cilastatin

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 th day

Secondary outcomes

  1. MRSA eradication

    Time frame: 14th day

  2. mortality

    Time frame: 28th day

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 15616274 ↗
  • 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. PubMed 16801442 ↗
  • 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. PubMed 11170948 ↗
  • 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. PubMed 16195255 ↗
  • 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. PubMed 12015695 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01356472
Lead sponsor
Ruijin Hospital
Collaborators
Pfizer
First posted
May 19, 2011
Start date
Jun 2011
Primary completion
Jun 2013 (estimated)
Last update
May 19, 2011

Study contacts

Zhi-Tao Yang, M.D.
Contact
yangzhitao@hotmail.fr
008613611965436
Er-Zhen Chen, M.D. & Ph.D.
study director · Emergency intensive care unit, Ruijin Hospital
Hong-Ping Qu, M.D.
principal investigator · Respiratory intensive care unit, Ruijin Hospital
Yu-Xing Ni, M.D. & Ph.D.
principal investigator · Microbiology laboratory, Ruijin Hospital
Zhi-Tao Yang, M.D.
study chair · Emergency Department, Ruijin Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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