RAPid SOlution for Diagnosis of Respiratory Infection in Pediatric Intensive Care Unit (RAPSODI)

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

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).

Study Overview

• Status: Completed
• Conditions: Severe Infections Pneumonia With Invasive Ventilation in PICU
• Intervention / Treatment: Diagnostic test: FILMARRAY® Pneumonia Plus Panel technique

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Robert Debré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Percentage of diagnostic agreement between the FilmArray result carried out on protected distal samples and the result of the reference method and description of the microorganisms most frequently found in cases of discrepancies.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To establish the percentage of invalid analyzes on this type of sample.	Number of invalid analyzes out of the total number of analyzes performed on protected sample with the FilmArray.	24 months
Rate of true positives (agreement of positive results between new strategy and reference method)		24 months
Rate of true negatives (agreement of negative results between new strategy and reference method).		24 months
To establish the diagnostic time saving in real life use.	Differential in final rendering time between the new strategy and the reference method.	24 months
Number of diagnoses adjusted on the number of diagnoses sought in children whose sample was taken after antibiotic therapy.	Number of diagnoses adjusted on the number of diagnoses sought in children whose sample was taken after antibiotic therapy.	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Pneumonia; Pediatrics; Mechanical ventilation; Multiplex PCR
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Infections; Pneumonia
• Other Study ID Numbers: APHP20132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No