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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01356472
Enrollment
60
Registered
2011-05-19
Start date
2011-06-30
Completion date
Unknown
Last updated
2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methicillin-resistant Staphylococcus Aureus, Pneumonia, Ventilator-Associated

Keywords

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

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.

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.

Interventions

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

Sponsors

Pfizer
CollaboratorINDUSTRY
Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MRSA eradication7 th dayThe 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.

Secondary

MeasureTime frame
MRSA eradication14th day
mortality28th day

Contacts

Primary ContactZhi-Tao Yang, M.D.
yangzhitao@hotmail.fr008613611965436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026