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

NCT ID: NCT04773704

Last Updated: 2022-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2022-01-18

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.

Conditions

Severe Infections Pneumonia With Invasive Ventilation in PICU

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

FILMARRAY® Pneumonia Plus Panel technique

FILMARRAY® Pneumonia Plus Panel technique (multiplex PCR) on a respiratory sample

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

multiplex PCR

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Robert Debré Hospital

Paris, , France

Countries

France

References

Geslain G, Cointe A, Naudin J, Dauger S, Poey N, Pages J, Le Roux E, Bonacorsi S. Diagnostic Accuracy of Blind Bronchial Sample Testing by BioFire Pneumonia plus Panel in Pediatric Intensive Care Unit Patients and Its Impact in Early Adaptation of Antimicrobial Therapy: A Prospective Observational Study. Pediatr Infect Dis J. 2024 Aug 1;43(8):725-730. doi: 10.1097/INF.0000000000004349. Epub 2024 Apr 8.

Reference Type: DERIVED

PMID: 38621162 (View on PubMed)

Other Identifiers

APHP20132

Identifier Type: -

Identifier Source: org_study_id