Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation

Study Overview
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Brief Summary
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The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment. The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.

Official Title
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Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial

Conditions
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Aspiration Pneumonia

Intervention / Treatment
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* Procedure: PCR-based microbiological diagnosis strategy
* Procedure: Standard microbiological diagnosis strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of risk factors for aspiration : known or likely swallowing dysfunction, altered consciousness, cardiac arrest, difficult intubation witnessed aspiration symptoms and signs suggestive of lower respiratory tract pathology temperature ≥38.5°C or <36°C leukocyte count ≥10 000/µL or <1500/µL purulent sputum or tracheal aspirate. new radiographic infiltrate on chest X-ray tracheal intubation and mechanical ventilation since less than 48 hours Exclusion Criteria: pregnant women refuse to participate to the study no informed consent documented bacteremia septic shock severe immunosuppression: leukocytes<1000/L or neutrophils<500/L, chemotherapy during the last 3 months, organ transplant with chronic immunosuppressors use, HIV (CD4<50), and chronic corticosteroid use (>0.5 mg/kg day for at least one month during the last three months). moribund patients (SAPS II >90).

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multiplex PCR strategy<br>FilmArray® Pneumonia Panel plus | Procedure: PCR-based microbiological diagnosis strategy<br>* A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation<br>|
| Active Comparator: standard strategy<br> | Procedure: Standard microbiological diagnosis strategy<br>* Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment |  | 48 hours after antibiotic treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of patients who will receive appropriate antibiotic treatment. |  | at Day 28 and Day 90 after antibiotic treatment initiation | 
| the percentage of patients who will receive targeted antibiotic treatment. |  | at Day 28 and Day 90 after antibiotic treatment initiation | 
| mechanical ventilation free days. |  | at Day 28 and Day 90 after antibiotic treatment initiation | 
| length of ICU stay. |  | up to Day 90 | 
| ICU mortality. |  | up to Day 90 | 
| antibiotic free days. |  | up to Day 90 | 
| percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR) |  | at Day 28 and Day 90 after antibiotic treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspiration pneumonia, Invasive ventilation, PCR, Antibiotics, Tracheal aspirate