RAPid SOlution for Diagnosis of Respiratory Infection in Pediatric Intensive Care Unit
Condition: Severe Infections Pneumonia With Invasive Ventilation in PICU
MeSH terms: Infections; Pneumonia
Study type: Observational

Summary: 
      In patients with infectious pneumonitis, the FILMARRAY® Pneumonia Plus Panel technique
      (multiplex PCR) on a respiratory sample makes it possible to identify the responsible
      pathogen and its resistance to antibiotics in less than an hour and therefore to quickly
      adapt the anti- infectious. FILMARRAY® Pneumonia Plus has been validated on two types of
      specimens from adult intubated patients, tracheal aspirations and bronchoalveolar lavage. It
      has not been validated on protected distal samples which are nevertheless used in current
      practice. This project will study the diagnostic validity of this technique performed on this
      type of sample. If the validity is demonstrated, this will allow this technique to be used on
      the protected distal sample which is a reliable sample and used in the context of respiratory
      infections, in particular acquired under ventilation in children (bronchoalveolar lavage is
      less easy and little used in practice in children).
    

Detailed description: 
      In patients with infectious pneumonitis, the FILMARRAY® Pneumonia Plus Panel technique
      (multiplex PCR) on a respiratory sample makes it possible to identify the responsible
      pathogen and its resistance to antibiotics in less than an hour and therefore to quickly
      adapt the anti- infectious. FILMARRAY® Pneumonia Plus has been validated on two types of
      specimens from adult intubated patients, tracheal aspirations and bronchoalveolar lavage. It
      has not been validated on protected distal samples which are nevertheless used in current
      practice. This project will study the diagnostic validity of this technique performed on this
      type of sample. If the validity is demonstrated, this will allow this technique to be used on
      the protected distal sample which is a reliable sample and used in the context of respiratory
      infections, in particular acquired under ventilation in children (bronchoalveolar lavage is
      less easy and little used in practice in children).

      As a result, this will allow a faster etiological diagnosis and adapted antibiotic therapy,
      guaranteeing better efficacy and a fairer antibiotic prescription.

      Currently no studies concerning the FILMARRAY® Pneumonia Plus Panel are ongoing or have been
      performed with the protected distal samples.

      This study would be innovative and unique in looking at its feasibility and validity on a
      type of sample used in current practice.

      In addition, the use of a PCR-based technique allows a rapid microbiological diagnosis of
      lower respiratory infections under invasive mechanical ventilation, compared to the reference
      technique requiring 48 to 72 hours to give a definitive result.

      This much shorter period allows for an appropriate antibiotic therapy early in the treatment,
      and potentially a reduction in ventilation and hospitalization times.

      In addition, it detects antibiotic resistance genes allowing rapid identification of
      multi-resistant bacteria (resistant Staphylococcus aureus meticillin, enterobacteria
      producing ESBLs or carbapenemases) and thus adapting antibiotic therapy.

      Our study will assess its diagnostic validity for the identification of the microorganisms
      responsible for pneumonia in intensive care and their resistance to antibiotics.
    

Intervention name(s): FILMARRAY® Pneumonia Plus Panel technique
Intervention type(s): Diagnostic Test
Intervention description(s): FILMARRAY® Pneumonia Plus Panel technique (multiplex PCR) on a respiratory sample
Other intervention name(s): multiplex PCR
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients hospitalized in pediatric intensive care unit, under mechanical ventilation
        (intubated or tracheostomized) with suspicion of infectious pneumonia
      
Keywords: Pneumonia; Pediatrics; Multiplex PCR; Mechanical ventilation