Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-03-29 @ 12:12 AM
Study NCT ID:
NCT01562769
Status:
TERMINATED
Last Update Posted:
2015-08-21
First Post:
2012-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'whyStopped': 'enrollment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-20', 'studyFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2012-03-23', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acquisition rate of micro-organisms', 'timeFrame': '2 years', 'description': 'Acquisition rate using bacteriological sampling (nose and anus) at admission and at the day of discharge in each patient hospitalized in the department.'}], 'secondaryOutcomes': [{'measure': 'Number of infections acquired during hospitalization in each group', 'timeFrame': '2 years'}, {'measure': 'Consumption of hydro-alcoholic rub in each group', 'timeFrame': '2 years'}, {'measure': 'Utilization of aprons and gloves in each group', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Patients Hospitalized in Infectious Disease']}, 'descriptionModule': {'briefSummary': 'Application of isolation (=contact precautions) in hospitalized patients is recommended when patient is colonized (or infected) by micro-organism known for its outbreak capacity or high pathogenicity. It allows the reinforcement of universal precautions (=standard precautions) in order to control patient-to-patient micro-organisms transmission. Recently, the efficacy of this measure is questioned and its impact on patient care seems deleterious.\n\nIn a particular context of Infectious Disease Unit, where standard precautions are handled (favorable architecture and appropriate practice for hand hygiene), assessment of contact precautions to reduce the incidence of acquired bacteria during hospitalization would be of interest.\n\nThe investigators design a non-inferiority comparative study to measure the colonization pressure in patients hospitalized in two different parts of the department: one unit only with standard precautions applied (intervention) and one unit with contact precautions (control) as current routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in Infectious Disease Unit of university-affiliated hospital in Rennes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient hospitalized in Infectious Diseases Unit during the study period in one of the selected part of the unit participating to the study\n* Patient informed about the study protocol and approved to participate.\n\nExclusion Criteria:\n\n* Patient requiring isolation prescription type "air" or "droplet"\n* Patient hospitalized in the central sector of the building (including 4 bedrooms in depression negative service)\n* Patient colonized with bacteria producing carbapenemase, multi-resistant Acinetobacter baumanii or Vancomycin-Resistant Enterococcus.\n* Patients under legal protection (juridical protection, legal guardianship) or persons on juridical detention.'}, 'identificationModule': {'nctId': 'NCT01562769', 'acronym': 'ISOL/STAND', 'briefTitle': 'Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes', 'orgStudyIdInfo': {'id': '2011-A01360-41'}, 'secondaryIdInfos': [{'id': 'LOC/11-20', 'type': 'OTHER', 'domain': 'Rennes University Hospital (Direction of Clinical Research)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard precautions', 'description': 'One selected part of the unit keep the usual procedure applied in our institution with contact precautions prescriptions when colonized patient is admitted with SA and/or ESBL bacteria.\n\nSecond selected part of the unit applies only standard precautions (even for patients colonized with multiple drug-resistant organisms).\n\nAfter 8 months precaution procedures will be exchanged between the two sectors (cross over design).'}, {'label': 'contact precautions', 'description': 'One selected part of the unit keep the usual procedure applied in our institution with contact precautions prescriptions when colonized patient is admitted with SA and/or ESBL bacteria.\n\nSecond selected part of the unit applies only standard precautions (even for patients colonized with multiple drug-resistant organisms).\n\nAfter 8 months precaution procedures will be exchanged between the two sectors (cross over design).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'state': 'Brittany Region', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'jean-marc chapplain', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}