Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04131569
Status:
UNKNOWN
Last Update Posted:
2019-10-21
First Post:
2019-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gut Microbiota Association With ESBL-E Colonisation and Subsequent ESBL-E Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'rectal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-17', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association of gut bacteriobiota with ventilator-associated pneumonia', 'timeFrame': 'at admission', 'description': 'Patients with oro-tracheal intubation for more than 48 hours among those included will be included in this ancillary analysis. Association of alpha and beta diversities for both gut bacteriobiota and mycobiota with subsequent ventilator-associated pneumoniae will be assessed'}, {'measure': 'Association of gut bacteriobiota with intensive care unit mortality', 'timeFrame': 'at admission', 'description': 'Association of alpha and beta diversities for both gut bacteriobiota and mycobiota with subsequent intensive care unit mortality will be assessed'}], 'primaryOutcomes': [{'measure': 'Gut bacteriobiota diversity according to ESBL specie', 'timeFrame': 'at positive screening', 'description': 'Comparison of gut bacteriobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers'}], 'secondaryOutcomes': [{'measure': 'Gut mycobiota diversity according to ESBL specie', 'timeFrame': 'at positive screening', 'description': 'Comparison of gut mycobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers'}, {'measure': 'Gut bacteriobiota diversity according to ESBL specie', 'timeFrame': 'at positive screening', 'description': 'Analysis of gut bacteriobiota beta diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers'}, {'measure': 'Gut mycobiota diversity according to ESBL specie', 'timeFrame': 'at positive screening', 'description': 'Analysis of gut mycobiota beta diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers'}, {'measure': 'bacteria and the absence of ESBL E. coli fecal carriage', 'timeFrame': 'at admission', 'description': 'Association of bacteria with the absence of ESBL E. coli fecal carriage by LefSe method'}, {'measure': 'fungi and the absence of ESBL E. coli fecal carriage', 'timeFrame': 'at admission', 'description': 'Association of fungi with the absence of ESBL E. coli fecal carriage by LefSe method'}, {'measure': 'fungi and the absence of ESBL K. pneumoniae fecal carriage', 'timeFrame': 'at admission', 'description': 'Association of fungi with the absence of ESBL K. pneumoniae fecal carriage by LefSe method'}, {'measure': 'bacteria and the absence of ESBL K. pneumoniae fecal carriage', 'timeFrame': 'at admission', 'description': 'Association of bacteria with the absence of ESBL K. pneumoniae fecal carriage by LefSe method'}, {'measure': 'Gut bacteriobiota and subsequent ESBL-E infection', 'timeFrame': 'at admission', 'description': 'Comparison of gut bacteriobiota alpha diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected.'}, {'measure': 'Gut bacteriobiota and subsequent ESBL-E infection', 'timeFrame': 'at admission', 'description': 'Analysis of gut bacteriobiota beta diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected'}, {'measure': 'Gut mycobiota and subsequent ESBL-E infection', 'timeFrame': 'at admission', 'description': 'Comparison of gut mycobiota alpha diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected.'}, {'measure': 'Gut mycobiota and subsequent ESBL-E infection', 'timeFrame': 'at admission', 'description': 'Analysis of gut mycobiota beta diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected'}, {'measure': 'Bacteria and the absence of subsequent ESBL-E infection', 'timeFrame': 'at admission', 'description': 'Association of bacteria with ESBL-E subsequent infection among ESBL-E fecal carriers by LefSe method'}, {'measure': 'Fungi and the absence of subsequent ESBL-E infection', 'timeFrame': 'at admission', 'description': 'Association of fungi with ESBL-E subsequent infection among ESBL-E fecal carriers by LefSe method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESBL-E', 'fecal carriage', 'microbiota', 'nosocomial infection'], 'conditions': ['Extended Spectrum Beta-Lactamase Producing Bacteria Infection', 'Microbial Colonization', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '37014580', 'type': 'DERIVED', 'citation': "Prevel R, Enaud R, Orieux A, Camino A, Sioniac P, M'Zali F, Dubois V, Berger P, Boyer A, Delhaes L, Gruson D. Bridging gut microbiota composition with extended-spectrum beta-lactamase Enterobacteriales faecal carriage in critically ill patients (microbe cohort study). Ann Intensive Care. 2023 Apr 4;13(1):25. doi: 10.1186/s13613-023-01121-0."}]}, 'descriptionModule': {'briefSummary': 'Antimicrobial resistance is a major threat worldwide and extended-spectrum beta-lactamase producing Enterobacteriales (ESBL-E) are a leading cause because of their wide dissemination. Gut microbiota seems to be correlated with multi-drug resistant organism carriage. This study thus aims to analyse the correlation between gut microbiota, ESBL-E fecal carriage and subsequent infection.', 'detailedDescription': 'The rising antimicrobial resistance has led to more than 33,000 deaths in Europe in 2015. Among them, extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) are the most frequent in Europe and have disseminated both in the community and in healthcare settings. Some studies have suggested that microbiota could be different between multi-drug resistant organisms, with different relative abundances of some bacteria. One study focused on ESBL-E fecal carriers, but in the community, with Bacteroides uniformis being more abundant in ESBL-E non-carriers than carriers. As identification of species discriminating between ESBL-E fecal carriers and non-carriers could pave the way for the design of ESBL-E carriage eliminating probiotics, we aim to analyse the correlation between gut microbiota and ESBL-E fecal carriage.\n\nMoreover, mechanisms in the link between ESBL-E fecal carriage and subsequent ESBL-E infection remain, so far, poorly understood and this study aims to provide a first insight in the involvement of gut microbiota in the link between colonization and infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Every in-patients admitted to our medical intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient above 18 year-old admitted to intensive care unit\n* ESBL-E fecal carriage according to current screening recommendations for ESBL-E carriage group\n* Feces quantity on rectal swab adequate for routine screening and microbiota analysis\n\nExclusion Criteria:\n\n* Guardianship, curatorship, or prisoners\n* No health insurance\n* No legal representative'}, 'identificationModule': {'nctId': 'NCT04131569', 'acronym': 'Microbe', 'briefTitle': 'Gut Microbiota Association With ESBL-E Colonisation and Subsequent ESBL-E Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of Bordeaux'}, 'officialTitle': 'Association of Gut Microbiota Diversity With Extended-spectrum Beta-lactamase Producing Enterobacteriales Fecal Carriage and Subsequent Infection in Intensive Care Unit: Microbe Study', 'orgStudyIdInfo': {'id': 'Microbe'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESBL-E fecal carriers', 'description': 'Patients with a positive ESBL-E fecal carriage according to routine screening', 'interventionNames': ['Diagnostic Test: ESBL-E fecal carriage screening according to routine care']}, {'label': 'non ESBL-E fecal carriers', 'description': 'Patients without positive ESBL-E fecal carriage according to routine screening', 'interventionNames': ['Diagnostic Test: ESBL-E fecal carriage screening according to routine care']}], 'interventions': [{'name': 'ESBL-E fecal carriage screening according to routine care', 'type': 'DIAGNOSTIC_TEST', 'description': 'ESBL-E fecal carriage screening according to routine care', 'armGroupLabels': ['ESBL-E fecal carriers', 'non ESBL-E fecal carriers']}]}, '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, Pelelgrin 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'}}}}