Informations générales (source: ClinicalTrials.gov)
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 (APAPI)
Interventional
N/A
University Hospital, Lille (Voir sur ClinicalTrials)
septembre 2019
mars 2025
08 mars 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHU - Lille - France | Saad Nseir | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Amiens Picardie - Amiens - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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).