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Ventilator-associated pneumonia (VAP) remains one of the main nosocomial infections acquired in the intensive care unit (ICU). VAP is pneumonia occurring 48 hours after intubation. Today, bronchoalveolar lavage (BAL) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. Multiplex PCR can detect DNA of a number of bacteriae, as well as the presence of resistance genes. However, its clinical value in the ICU remains to be demonstrated. We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP, could be an interesting method for clinicians in ICU.
Ventilator-associated pneumonia (VAP) remains one of the main nosocomial infections acquired in the intensive care unit (ICU). VAP is pneumonia occurring 48 hours after intubation. Today, bronchoalveolar lavage (BAL) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. Multiplex PCR can detect the bacterial DNA of a number of bacteria, as well as the presence of resistance genes. However, its clinical value in the ICU remains to be demonstrated. We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP, could be an interesting method for clinicians in ICU.
The aim of our study is to compare the percentage of appropriate empirical antibiotic therapy in the group benefiting from multiplex PCR on BAL prior to bacterial culture results compared to control group (bacterial culture alone=usual management) in patients with culture-confirmed VAP.
This is a multicenter, randomized, controlled, French study conducted in 8 university intensive care units (2 surgical units, 6 medical units) in the Grand-Est region of France. The multiplex PCR tested here is BioFire's FilmArray Pneumonia Panel Plus. It is performed solely on per-fibroscopic bronchoalveolar lavage (BAL) fluids in cases of suspected VAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental |
| |
| control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiplex PCR | Device | In the intervention group (Multiplex PCR performed and results communicated to the clinician), bronchoalveolar lavage will be examined directly after Gram staining by the laboratory, followed by quantitative culture. A multiplex PCR will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of appropriate empirical antibiotic therapy in cases of culture-confirmed VAP, according to the diagnostic method used (multiplex PCR or not). | The appropriate antibiotic is one that is effective against the diagnosed pathogen and has the narrowest possible antibiotic spectrum. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of effective antibiotic treatment for the identified germ in each group. | The effective antibiotic is one that is effective against the diagnosed pathogen. | Day 14 |
| Duration of inappropriate antibiotic therapy (in hours) in each group |
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inclusion criteria :
exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine GOURY | Contact | 03 10 73 68 85 | 0033 | agoury@chu-reims.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damien JOLLY | Recruiting | Reims | France |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D004194 | Disease |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D060885 | Multiplex Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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An inappropriate antibiotic is one that is not active according to the in vitro antibiogram of the identified pathogen, or whose spectrum is too broad for the resistance profile of the identified pathogen.
| Day 14 |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |