Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT04773704
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2021-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RAPid SOlution for Diagnosis of Respiratory Infection in Pediatric Intensive Care Unit
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPSODI
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: