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OpenTrials
Completed

NCT Number: NCT04773704

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

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).

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Key information

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Debré Hospital

Paris, 75019, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FILMARRAY® Pneumonia Plus Panel technique

Diagnostic Test

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

Other names: multiplex PCR

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Rate of true positives (agreement of positive results between new strategy and reference method)

    Time frame: 24 months

  3. Rate of true negatives (agreement of negative results between new strategy and reference method).

    Time frame: 24 months

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: RAPSODI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2021
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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