Aspiration Pneumonia
Conditions
Keywords
Aspiration pneumonia, Invasive ventilation, PCR, Antibiotics, Tracheal aspirate
Brief summary
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.
Interventions
PROCEDUREPCR-based microbiological diagnosis strategy
A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
PROCEDUREStandard microbiological diagnosis strategy
Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| the percentage of patients who will receive appropriate antibiotic treatment. | at Day 28 and Day 90 after antibiotic treatment initiation |
| 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 |
| ICU mortality. | up to Day 90 |
Countries
France
Outcome results
None listed