Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-06 @ 1:58 AM
Study NCT ID:
NCT02717767
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'tracheal aspirate and bronchoalveolar lavages'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-18', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pneumonia', 'timeFrame': '28 days', 'description': 'Diagnosis of pneumonia (Clinical Pulmonary Infection Score \\> 6, with assessment of the chest radiography by a blinded investigator)'}], 'secondaryOutcomes': [{'measure': 'Clinical Pulmonary Infection Score > 6', 'timeFrame': 'day 3'}, {'measure': 'Acute respiratory distress syndrome', 'timeFrame': 'day 90', 'description': 'PaO2/FiO2 \\< 200 with a PEEP \\> 5 (Berlin definition)'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': 'day 90'}, {'measure': 'Intensive Care unit Length of stay', 'timeFrame': 'day 90'}, {'measure': 'Mortality', 'timeFrame': 'day 90'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pneumonia', 'diagnosis', 'prognosis', 'tracheal aspirate', 'bronchoalveolar lavage'], 'conditions': ['Pneumonia']}, 'referencesModule': {'references': [{'pmid': '24658436', 'type': 'BACKGROUND', 'citation': 'Monsel A, Lecart S, Roquilly A, Broquet A, Jacqueline C, Mirault T, Troude T, Fontaine-Aupart MP, Asehnoune K. Analysis of autofluorescence in polymorphonuclear neutrophils: a new tool for early infection diagnosis. PLoS One. 2014 Mar 21;9(3):e92564. doi: 10.1371/journal.pone.0092564. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The diagnosis of pneumonia is challenging in Intensive Care Unit. The auto-fluorescence of white corpuscles is altered during pneumonia. In presence of bacterial growth on lung samples, the measure of autofluorescence of white corpuscles could help the clinicians to discriminate bacterial colonization from acute infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in intensive care units', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalization in intensive care units\n* Mechanical ventilation\n* Age \\> 18 years\n* Collection of a lung sample for bacteriological analysis for the suspicion of a first episode of lung infection.\n\nExclusion Criteria:\n\n* Refuse to participate'}, 'identificationModule': {'nctId': 'NCT02717767', 'acronym': 'BIONAGA', 'briefTitle': 'Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in Intensive Care Units', 'orgStudyIdInfo': {'id': 'RC15_0081'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Autofluorescence of white corpuscle', 'type': 'OTHER', 'description': 'Measure of auto-fluorescence of white corpuscles cells harvested from tracheal aspirate and/or bronchoalveolar lavages'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41016', 'city': 'Blois', 'country': 'France', 'facility': 'Blois Hospital', 'geoPoint': {'lat': 47.59432, 'lon': 1.32912}}, {'zip': '22000', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Saint-Brieuc Hospital', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '44606', 'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'Saint-NazaireHospital', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '56017', 'city': 'Vannes', 'country': 'France', 'facility': 'Vannes Hospital', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'overallOfficials': [{'name': 'Antoine ROQUILLY, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}