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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Drug: Imipenem/cilastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Linezolid alone<br>the control group is designed for linezolid alone treated MRSA VAP (standard treatment). | Drug: Imipenem/cilastatin<br>* the intervention group was designed for combined linezolid plus imipenem for treating MRSA VAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRSA eradication |  | 14th day | 
| mortality |  | 28th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methicillin-resistant Staphylococcus aureus, Pneumonia, Ventilator-Associated, linezolid, imipenem/cilastatin