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

NCT01356472 | Unknown Phase 4 DMC

• 1 other identifier: MRSA-VAP YANG ZT CN
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Methicillin-resistant Staphylococcus Aureus; Pneumonia, Ventilator-Associated

Keywords

Methicillin-resistant Staphylococcus aureus; Pneumonia, Ventilator-Associated; linezolid; imipenem/cilastatin

Outcome Measures

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.

  7 th day

Secondary Outcomes (2)

• MRSA eradication

  14th day

• mortality

  28th day

Study Arms (1)

Linezolid alone

NO INTERVENTION

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

Drug: Imipenem/cilastatin

Interventions

Imipenem/cilastatin DRUG

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

Linezolid alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead
• Pfizer: collaborator

Related Publications (5)

• 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.

  PMID: 15616274 BACKGROUND

• 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.

  PMID: 16801442 BACKGROUND

• 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.

  PMID: 11170948 BACKGROUND

• 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.

  PMID: 16195255 BACKGROUND

• 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.

  PMID: 12015695 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Cilastatin, Imipenem Drug Combination

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imipenem; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Er-Zhen Chen, M.D. & Ph.D.

  Emergency intensive care unit, Ruijin Hospital

  STUDY DIRECTOR

• Hong-Ping Qu, M.D.

  Respiratory intensive care unit, Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Yu-Xing Ni, M.D. & Ph.D.

  Microbiology laboratory, Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Zhi-Tao Yang, M.D.

  Emergency Department, Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Zhi-Tao Yang, M.D.

CONTACT

008613611965436; yangzhitao@hotmail.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: May 19, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Last Updated: May 19, 2011

Record last verified: 2011-04