Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04773704 |
| Other study ID # |
APHP20132 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 29, 2021 |
| Est. completion date |
January 18, 2022 |
Study information
| Verified date |
February 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
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.
