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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75019
- Robert Debre Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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)
Time Frame: 1 week
|
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.
Time Frame: 24 months
|
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)
Time Frame: 24 months
|
24 months
|
|
|
Rate of true negatives (agreement of negative results between new strategy and reference method).
Time Frame: 24 months
|
24 months
|
|
|
To establish the diagnostic time saving in real life use.
Time Frame: 24 months
|
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.
Time Frame: 24 months
|
Number of diagnoses adjusted on the number of diagnoses sought in children whose sample was taken after antibiotic therapy.
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP20132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.