Severe Infections Pneumonia With Invasive Ventilation in PICURAPSODINCT04773704
RAPid SOlution for Diagnosis of Respiratory Infection in Pediatric Intensive Care Unit
An observational study of Severe Infections Pneumonia With Invasive Ventilation in PICU, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Severe Infections Pneumonia With Invasive Ventilation in PICU
- What is being tested?
- FILMARRAY® Pneumonia Plus Panel technique
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2021to 18 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients hospitalized in pediatric intensive care unit, under mechanical ventilation (intubated or tracheostomized) with suspicion of infectious pneumonia
Who may be able to join
- Patients hospitalized in pediatric intensive care
- Patients under mechanical ventilation (intubated or tracheostomized)
- Age <18 years old
Who cannot join
- Contraindications to protected distal sampling
- Refusal to participate by at least one parent or legal guardian(s)
- Patient not covered by health insurance
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- FILMARRAY® Pneumonia Plus Panel technique
- Keywords
- Pneumonia, Pediatrics, Multiplex PCR, Mechanical ventilation
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FILMARRAY® Pneumonia Plus Panel techniqueDiagnostic test
Also called multiplex PCR
FILMARRAY® Pneumonia Plus Panel technique (multiplex PCR) on a respiratory sample
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (5)
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.
Measured: 24 months
Rate of true positives (agreement of positive results between new strategy and reference method)
Measured: 24 months
Rate of true negatives (agreement of negative results between new strategy and reference method).
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start29 Apr 2021
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Infections Pneumonia With Invasive Ventilation in PICUStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773704
- Sponsor's protocol ID
- APHP20132
- Acronym
- RAPSODI
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38621162
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04773704
- Acronym / sponsor ID
- RAPSODI / APHP20132
- Keywords
- Pneumonia, Pediatrics, Multiplex PCR, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients hospitalized in pediatric intensive care unit, under mechanical ventilation (intubated or tracheostomized) with suspicion of infectious pneumonia
Key inclusion criteria (3 listed)
- Patients hospitalized in pediatric intensive care
- Patients under mechanical ventilation (intubated or tracheostomized)
- Age <18 years old
Key exclusion criteria (3 listed)
- Contraindications to protected distal sampling
- Refusal to participate by at least one parent or legal guardian(s)
- Patient not covered by health insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FILMARRAY® Pneumonia Plus Panel techniqueAlso: multiplex PCRFILMARRAY® Pneumonia Plus Panel technique (multiplex PCR) on a respiratory sample | Diagnostic test | – |
Primary outcome
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.
5 secondary outcomes
To establish the percentage of invalid analyzes on this type of sample.
Time frame: 24 months
Rate of true positives (agreement of positive results between new strategy and reference method)
Time frame: 24 months
Rate of true negatives (agreement of negative results between new strategy and reference method).
Time frame: 24 months
To establish the diagnostic time saving in real life use.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Derived from this study: PubMed 38621162Geslain 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Infections Pneumonia With Invasive Ventilation in PICU, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04773704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.