Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 1:37 AM
Study NCT ID:
NCT03477760
Status:
COMPLETED
Last Update Posted:
2018-03-26
First Post:
2018-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Drug Resistant Bacteria Carriage After Travel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'frozen stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-18', 'studyFirstSubmitDate': '2018-03-18', 'studyFirstSubmitQcDate': '2018-03-18', 'lastUpdatePostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multi-Drug Resistant bacteria carriage rate', 'timeFrame': 'At admission in our Hospital', 'description': 'Multi-Drug Resistant bacteria carriage assessed by rectal swab'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Beta Lactam Resistant Bacterial Infection (Disorder)']}, 'descriptionModule': {'briefSummary': 'During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent). They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel.', 'detailedDescription': 'During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent), regardless a travel in a foreign country during the past year, or not. They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel. The aim of the study will be to compare the rate of carriage of multi-drug resistant bacteria among previous travelers, or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted in one of the medical Dpt of our Hospital who have travelled in a foreign country during the previous year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted in one of the medical Dpt of our Hospital who have travelled in a foreign country during the previous year\n\nExclusion Criteria:\n\n* patients who were unable to give written consent'}, 'identificationModule': {'nctId': 'NCT03477760', 'briefTitle': 'Multi-Drug Resistant Bacteria Carriage After Travel', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Lariboisière'}, 'officialTitle': 'Multi-Drug Resistant Bacteria Carriage After Travel: Comparison Between Patients Who Have Been Hospitalized in a Foreign Country, or Not During the Previous Year', 'orgStudyIdInfo': {'id': 'MRB after travel'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rectal swab for Multi-Drug resistant bacteria', 'type': 'BIOLOGICAL', 'description': 'A rectal swab will be performed at admission of patients to look for intestinal carriage of Multi-Drug resistant bacteria'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75475', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'URT, Hopital Lariboisiere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pierre O Sellier, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hopital Lariboisiere'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Lariboisière', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Célia Lloret-Linares, MD PhD', 'investigatorAffiliation': 'Hopital Lariboisière'}}}}