Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-29 @ 9:54 PM
Study NCT ID:
NCT04773704
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2021-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RAPid SOlution for Diagnosis of Respiratory Infection in Pediatric Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'timeFrame': '1 week', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'To establish the percentage of invalid analyzes on this type of sample.', 'timeFrame': '24 months', 'description': 'Number of invalid analyzes out of the total number of analyzes performed on protected sample with the FilmArray.'}, {'measure': 'Rate of true positives (agreement of positive results between new strategy and reference method)', 'timeFrame': '24 months'}, {'measure': 'Rate of true negatives (agreement of negative results between new strategy and reference method).', 'timeFrame': '24 months'}, {'measure': 'To establish the diagnostic time saving in real life use.', 'timeFrame': '24 months', 'description': 'Differential in final rendering time between the new strategy and the reference method.'}, {'measure': 'Number of diagnoses adjusted on the number of diagnoses sought in children whose sample was taken after antibiotic therapy.', 'timeFrame': '24 months', 'description': 'Number of diagnoses adjusted on the number of diagnoses sought in children whose sample was taken after antibiotic therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumonia', 'Pediatrics', 'Multiplex PCR', 'Mechanical ventilation'], 'conditions': ['Severe Infections Pneumonia With Invasive Ventilation in PICU']}, 'referencesModule': {'references': [{'pmid': '38621162', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).\n\nAs a result, this will allow a faster etiological diagnosis and adapted antibiotic therapy, guaranteeing better efficacy and a fairer antibiotic prescription.\n\nCurrently no studies concerning the FILMARRAY® Pneumonia Plus Panel are ongoing or have been performed with the protected distal samples.\n\nThis study would be innovative and unique in looking at its feasibility and validity on a type of sample used in current practice.\n\nIn 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.\n\nThis much shorter period allows for an appropriate antibiotic therapy early in the treatment, and potentially a reduction in ventilation and hospitalization times.\n\nIn 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.\n\nOur study will assess its diagnostic validity for the identification of the microorganisms responsible for pneumonia in intensive care and their resistance to antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in pediatric intensive care unit, under mechanical ventilation (intubated or tracheostomized) with suspicion of infectious pneumonia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized in pediatric intensive care\n* Patients under mechanical ventilation (intubated or tracheostomized)\n* Age \\<18 years old\n\nExclusion Criteria:\n\n* Contraindications to protected distal sampling\n* Refusal to participate by at least one parent or legal guardian(s)\n* Patient not covered by health insurance'}, 'identificationModule': {'nctId': 'NCT04773704', 'acronym': 'RAPSODI', 'briefTitle': 'RAPid SOlution for Diagnosis of Respiratory Infection in Pediatric Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'APHP20132'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FILMARRAY® Pneumonia Plus Panel technique', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['multiplex PCR'], 'description': 'FILMARRAY® Pneumonia Plus Panel technique (multiplex PCR) on a respiratory sample'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Robert Debré Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}