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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Methicillin-resistant Staphylococcus Aureus; Pneumonia, Ventilator-Associated

Treatments: Drug: Imipenem/cilastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01356472

MRSA-VAP YANG ZT CN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Linezolid alone

No Intervention group

Description:

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

Treatment:

Drug: Imipenem/cilastatin