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

Information source: Ruijin Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Methicillin-resistant Staphylococcus Aureus; Pneumonia, Ventilator-Associated

Intervention: Imipenem/cilastatin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Ruijin Hospital

Official(s) and/or principal investigator(s):
Er-Zhen Chen, M.D. & Ph.D., Study Director, Affiliation: Emergency intensive care unit, Ruijin Hospital
Hong-Ping Qu, M.D., Principal Investigator, Affiliation: Respiratory intensive care unit, Ruijin Hospital
Yu-Xing Ni, M.D. & Ph.D., Principal Investigator, Affiliation: Microbiology laboratory, Ruijin Hospital
Zhi-Tao Yang, M.D., Study Chair, Affiliation: Emergency Department, Ruijin Hospital

Overall contact:
Zhi-Tao Yang, M.D., Phone: 008613611965436, Email: yangzhitao@hotmail.fr

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: MRSA eradication

Secondary outcome:

MRSA eradication

mortality

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Zhi-Tao Yang, M.D., Phone: 008613611965436, Email: yangzhitao@hotmail.fr

Additional Information

Related 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.

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.

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. Epub 2001 Jan 26.

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. Epub 2005 Sep 29.

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. Epub 2002 May 13.

Starting date: June 2011
Last updated: May 18, 2011

Page last updated: August 23, 2015

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