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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02219-46 | Other Identifier | ID-RCB number, ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multiplex PCR strategy | Experimental | FilmArray® Pneumonia Panel plus |
|
| standard strategy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCR-based microbiological diagnosis strategy | Procedure | A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saadalla NSEIR, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens Picardie | Amiens | France | ||||
| Hôpital Roger Salengro, CHU |
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| ID | Term |
|---|---|
| D011015 | Pneumonia, Aspiration |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
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| Standard microbiological diagnosis strategy | Procedure | Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation |
|
| 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 |
| Lille |
| France |
| D012140 |
| Respiratory Tract Diseases |