Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-31 @ 8:31 PM
Study NCT ID:
NCT04133558
Status:
UNKNOWN
Last Update Posted:
2019-11-01
First Post:
2019-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Microbiota and ARDS Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'tracheal aspirate'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-17', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lung bacteriobiota and ICU mortality', 'timeFrame': 'at admission', 'description': 'Comparison of lung bacteriobiota alpha diversity between ARDS ICU survivors and non-survivors'}], 'secondaryOutcomes': [{'measure': 'lung mycobiota and ICU mortality', 'timeFrame': 'at admission', 'description': 'Comparison of lung mycobiota alpha diversity between ARDS ICU survivors and non-survivors'}, {'measure': 'lung mycobiota and 1-month mortality', 'timeFrame': 'microbiota : at admission, mortality: 1 month after inclusion', 'description': 'Comparison of lung mycobiota alpha diversity between ARDS 1-month survivors and non-survivors'}, {'measure': 'lung bacteriobiota and ICU mortality', 'timeFrame': 'at admission', 'description': 'Analysis of lung bacteriobiota beta diversity between ARDS ICU survivors and non-survivors'}, {'measure': 'lung bacteriobiota and 1-month mortality', 'timeFrame': 'microbiota : at admission, mortality: 1 month after inclusion', 'description': 'Analysis of lung bacteriobiota beta diversity between ARDS 1-month survivors and non-survivors'}, {'measure': 'lung mycobiota and ICU mortality', 'timeFrame': 'at admission', 'description': 'Analysis of lung mycobiota beta diversity between ARDS ICU survivors and non-survivors'}, {'measure': 'lung mycobiota and 1-month mortality', 'timeFrame': 'microbiota : at admission, mortality: 1 month after inclusion', 'description': 'Analysis of lung mycobiota beta diversity between ARDS 1-month survivors and non-survivors'}, {'measure': 'bacteria and ICU mortality', 'timeFrame': 'at admission', 'description': 'Association of bacteria with ARDS ICU mortality by LefSe method'}, {'measure': 'bacteria and 1-month mortality', 'timeFrame': 'microbiota : at admission, mortality: 1 month after inclusion', 'description': 'Association of bacteria with ARDS 1-month mortality by LefSe method'}, {'measure': 'fungi and ICU mortality', 'timeFrame': 'at admission', 'description': 'Association of fungi with ARDS ICU mortality by LefSe method'}, {'measure': 'fungi and 1-month mortality', 'timeFrame': 'microbiota : at admission, mortality: 1 month after inclusion', 'description': 'Association of fungi with ARDS 1-month mortality by LefSe method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute respiratory distress syndrome', 'microbiota', 'intensive care unit'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'Acute respiratory distress syndrome (ARDS) is due to diffuse and severe lung inflammation. Despite intensive research, few therapeutics have emerged and treatment is still mostly symptomatic. As lung microbiota seems to be associated with lung inflammation in numerous chronic respiratory diseases, this study aims to analyse the correlation between lung microbiota and mortality.', 'detailedDescription': 'ARDS is caused by diffuse intense lun inflammation. Its mortality rate is still about 40%. Despite decades of research, few therapeutics have emerged. Treatment is based on the treatment of ARDS cause, if possible and on protective ventilation, curare use and prone position. For more severe cases, nitric monoxide inhalation and extra-corporeal membrane oxygenation can be considered. Nevertheless, no treatment specifically addresses lung inflammation. Lung microbiota has been shown to be associated with lung inflammation in asthma, chronic obstructive disease and cystic fibrosis. Lung microbiota also plays a role in lung immunity. Regarding specifically ARDS, one study correlated lung microbiota with the occurrence of non-infectious ARDS in trauma patients. Thi study therefore aims to analyse the correlation between lung microbiota at admission to ICU for ARDS with mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ARDS patients needing oro-tracheal intubation for mechanical ventilation in ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient above 18 year-old admitted to intensive care unit\n* ARDS according to Berlin criteria\n* Needing oro-tracheal intubation for mechanical ventilation\n* Within the first 48 hours of ARDS evolution\n\nExclusion Criteria:\n\n* Guardianship or curatorship\n* Prisoners\n* No health insurance\n* No legal representative'}, 'identificationModule': {'nctId': 'NCT04133558', 'acronym': 'MicrA', 'briefTitle': 'Pulmonary Microbiota and ARDS Mortality', 'organization': {'class': 'OTHER', 'fullName': 'University of Bordeaux'}, 'officialTitle': 'Association of Lung Microbiota With Intensive Care Unit Mortality in ARDS Patients: MicrA Study', 'orgStudyIdInfo': {'id': 'MicrA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tracheal aspirate during routine care', 'type': 'OTHER', 'description': 'tracheal aspirate during routine care'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'state': 'Nouvelle-Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Didier Gruson, Prof', 'role': 'CONTACT', 'email': 'didier.gruson@chu-bordeaux.fr', 'phone': '+33556795679'}, {'name': 'Renaud Prevel, MD, PhD', 'role': 'CONTACT', 'email': 'renaud.prevel@u-bordeaux.fr', 'phone': '+33556795679'}], 'facility': 'Medical intensive care unit, Pellegrin hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Dr Pauline Esteves', 'investigatorAffiliation': 'University of Bordeaux'}}}}