Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-03-12 @ 5:07 AM
Study NCT ID:
NCT03641235
Status:
UNKNOWN
Last Update Posted:
2018-08-21
First Post:
2018-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-17', 'studyFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of differents types of cyto-bacteriological of sputum in Bacteriology', 'timeFrame': 'Day 0', 'description': 'After extraction of the DNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity through the coefficient developed by Shannon and the β diversity'}, {'measure': 'Number of differents types of Cyto-bacteriological of sputum in Mycology', 'timeFrame': 'Day 0', 'description': 'After extraction of the DNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity through the coefficient developed by Shannon and the β diversity.'}, {'measure': 'Number of differents types of Cyto-bacteriological of sputum in Virology', 'timeFrame': 'Day 0', 'description': 'After extraction of the RNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity and the β diversity.'}, {'measure': 'Number of differents types of Cyto-bacteriological of sputum in Bacteriology', 'timeFrame': 'Day 60', 'description': 'After extraction of the DNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity through the coefficient developed by Shannon and the β diversity'}, {'measure': 'Number of differents types of Cyto-bacteriological of sputum in Mycology', 'timeFrame': 'Day 60', 'description': 'After extraction of the DNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity through the coefficient developed by Shannon.'}, {'measure': 'Number of differents types of Cyto-bacteriological of sputum in Virology', 'timeFrame': 'Day 60', 'description': 'After extraction of the RNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity and the β diversity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary microbiota', 'Chronic obstructive pulmonary disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the correlation between pulmonary microbiota dynamics (including bacteria, fungi and viruses) and COPD exacerbation for COPD patients admitted to ICU', 'detailedDescription': 'Chronic obstructive pulmonary disease (COPD) is a frequent cause of ICU admission. COPD exacerbations are a leading cause of lung function worsening and of morbimortality. Hospitalizations due to COPD exacerbations are highly expensive for health insurance system. Bacterial pulmonary microbiota has been shown to be correlated to the severity of COPD and to exacerbations. Nevertheless fungi and viruses which are full actors of pulmonary microbiota have not yet been investigated.\n\nOur primary outcome will be the assessment of alpha and beta diversity dynamics of the whole pulmonary microbiota (bacteria, fungi and viruses) between COPD exacerbation and steady state.\n\nThis study will prospectively include 24 patients at ICU admission for COPD exacerbation with sputum sampling. Steady-state as defined during a 2 months-later visit will be studied with another sputum collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient above 18 admitted in ICU, admitted for COPD exacerbation defined by sustained (\\> 2 days) worsening of respiratory symptoms considering Anthonisen's criteria with life-threatening condition.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient above 18 admitted in ICU\n* Admitted for COPD exacerbation defined by sustained (\\> 2 days) worsening of respiratory symptoms considering Anthonisen's criteria with life-threatening condition.\n* Needing mechanical ventilation (noninvasive ventilation or oro-tracheal intubation)\n* COPD condition will be presumed according to patient's respiratory history or previous lung function testing\n* Able to consent or with the patient's family consent\n* Affiliated to a social insurance scheme\n\nNo inclusion Criteria:\n\n* COPD patient admitted for another cause than respiratory failure\n* person under tutorship or curatorship\n* living further than 100 kilometers away from the ICU\n* expected survival inferior to 1 week\n\nExclusion Criteria\n\n\\- Lung function testing not consistent with COPD at steady-state visit"}, 'identificationModule': {'nctId': 'NCT03641235', 'acronym': 'ADMiRE', 'briefTitle': 'Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care', 'orgStudyIdInfo': {'id': 'CHUBX 2018/17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'exacerbating COPD patients needing ICU admission', 'description': 'sputum collection', 'interventionNames': ['Biological: Sputum collection']}], 'interventions': [{'name': 'Sputum collection', 'type': 'BIOLOGICAL', 'description': 'Analysis of Sputum collection', 'armGroupLabels': ['exacerbating COPD patients needing ICU admission']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Didier GRUSON, MD,PhD', 'role': 'CONTACT', 'email': 'didier.gruson@chu-bordeaux.fr', 'phone': '+335 56 79 55 17'}, {'name': 'Renaud PREVEL', 'role': 'CONTACT', 'email': 'renaud.prevel@u-bordeaux.fr', 'phone': '+335 56 79 55 17'}, {'name': 'Didier GRUSON, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital, Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'Didier GRUSON, MD/PhD', 'role': 'CONTACT', 'email': 'didier.gruson@chu-bordeaux.fr', 'phone': '+335 56 79 55 17'}, {'name': 'Renaud PREVEL, MD MSc', 'role': 'CONTACT', 'email': 'renaud.prevel@u-bordeaux.fr', 'phone': '+335 56 79 55 17'}], 'overallOfficials': [{'name': 'Didier GRUSON, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital University, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}