Clinical trial NCT04773704: RAPid SOlution for Diagnosis of Respiratory Infection in Pediatric Intensive Care Unit
Official title: Diagnostic Validity of a New Strategy for the Rapid Detection of Microorganisms and Their Resistance to Antibiotics Responsible for Pneumonia in Pediatric Intensive Care Units Using Protected Distal Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Infections Pneumonia With Invasive Ventilation in PICU
Keywords: Pneumonia
Pediatrics
Multiplex PCR
Mechanical ventilation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
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

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in pediatric intensive care
* Patients under mechanical ventilation (intubated or tracheostomized)
* Age \<18 years old

Exclusion Criteria:

* Contraindications to protected distal sampling
* Refusal to participate by at least one parent or legal guardian(s)
* Patient not covered by health insurance

Primary outcomes:
measure: concordance between the results of the FILMARRAY® Pneumonia on a protected distal sample (new strategy) and those obtained by culture and antibiogram (classic diagnosis, reference method)
timeFrame: 1 week
Secondary outcomes:
measure: To establish the percentage of invalid analyzes on this type of sample.
timeFrame: 24 months
measure: Rate of true positives (agreement of positive results between new strategy and reference method)
timeFrame: 24 months
measure: Rate of true negatives (agreement of negative results between new strategy and reference method).
timeFrame: 24 months
measure: To establish the diagnostic time saving in real life use.
timeFrame: 24 months
measure: Number of diagnoses adjusted on the number of diagnoses sought in children whose sample was taken after antibiotic therapy.
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré Hospital
Study officials:
References: