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
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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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Linezolid alone
the control group is designed for linezolid alone treated MRSA VAP (standard treatment).
Imipenem/cilastatin
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
Eligibility Criteria
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Inclusion Criteria
* 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
* colonized chronically with methicillin-resistant S. aureus
* pregnancy
* endotracheal aspiration culture showed no MRSA
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Ruijin Hospital
OTHER
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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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.
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.
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.
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.
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.
Other Identifiers
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MRSA-VAP YANG ZT CN
Identifier Type: -
Identifier Source: org_study_id
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