Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-17 @ 5:47 PM
Study NCT ID:
NCT02840656
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-07-20', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients with an oropharyngeal gram-negative colonization', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'incidence of the a GNB oropharyngeal colonization', 'timeFrame': 'Day 1'}, {'measure': 'comparision of the predominant fecal flora with GNB oropharyngeal colonization', 'timeFrame': 'Day 1'}, {'measure': 'characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonization', 'timeFrame': 'Day 1'}, {'measure': 'phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oropharyngeal Gram-negative Bacilli Colonization']}, 'descriptionModule': {'briefSummary': 'In this prospective observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in healthy subjects, and their susceptibility to chlorehexidine. We plan to recruit 100 healthy volunteers secondary endpoints are to determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal of predominant GNB colonization.', 'detailedDescription': 'In this prospective observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 100 healthy subjects, and their susceptibility to chlorehexidine. Each participant will undego a oropharyngeal swab collection and a rectal swab at day 0. The Gram-negative bacilli colonization will be identified, E. coli isolates will be studied in terms of phylogeny; gram-negative isolates will be studied in terms of antimicrobial and chlorhexidine susceptibility. The primary objective is to determine the prevalence of oropharyngeal Gram-negative bacilli colonization. The secondary objectives are to determine the chlorhexidine and antimicrobial susceptibility of such colonization; to determine the phylogentic characteristics of oropharyngeal and rectal predominant E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy volonteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 yo\n* personal history of neck or face irradiation\n* no history of gastrointestinal disease\n* no symptoms of immunosuppression\n* no antibiotic therapy in the previous month\n* no hospitalization in the 3 months preceding inclusion\n* medical exmination prior to inclusion\n\nExclusion Criteria:\n\n* affiliated to the social security\n* The refusal of a patient to participate in a study'}, 'identificationModule': {'nctId': 'NCT02840656', 'acronym': 'OroColi-HS', 'briefTitle': 'Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Healthy Adults Subjects', 'orgStudyIdInfo': {'id': 'P140907'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy adult subject', 'description': 'oropharyngeal and rectal swabbing to collect Gram-negative bacilli', 'interventionNames': ['Other: oropharyngeal swabbing', 'Other: rectal swabbing']}], 'interventions': [{'name': 'oropharyngeal swabbing', 'type': 'OTHER', 'description': 'microbiological sampling will be performed on buccal mucosa with standard swab. only one sample will be done', 'armGroupLabels': ['healthy adult subject']}, {'name': 'rectal swabbing', 'type': 'OTHER', 'description': 'same process as oropharyngeal swabbing will be used to collect rectal microbiological sample', 'armGroupLabels': ['healthy adult subject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92700', 'city': 'Colombes', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'AP-HP, Louis Mourier Hospital', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}], 'overallOfficials': [{'name': 'Jonathan MESSIKA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Louis Mourier - Assistance Publique Hopitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}