Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-21 @ 8:44 PM
Study NCT ID:
NCT02891902
Status:
COMPLETED
Last Update Posted:
2016-09-08
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Dedicated Hygienist Staff on the Occurrence of Intensive Care Unit -Aquired Bloodstream Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of first ICU acquired bloodstream infection for 100 admitted patients', 'timeFrame': '2 months', 'description': 'Collection of blood cultures'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intensive Care Unit -Aquired Bloodstream Infections.']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate in a multicentric cluster randomized study the effect of the presence of dedicated nurses for training of ICU staff in preventing nosocomial infections. The rate of bloodstream infections per 100 admitted patients is used as the main endpoint. A sample of 4000 included patients in the 6 participating ICU is included with the objective to show a reduction of one third of the rate of ICU-acquired bloodstream infections. The study is currently at the end of the recrutimeent phase.', 'detailedDescription': '15% of patients admitted to intensive care have an infection acquired in the service, including bacteremia is a serious form. Compliance with hygiene measures and recommendations in the use of invasive devices can reduce the incidence. The advantage of simple recommendations type "bundle" could, however, be insufficient because not associated with training and monitoring compliance with the recommendations. The aim of this study is to show that the daily intervention of a public health nurse on the basis of a half full-time equivalent, allows these actions and therefore a reduction in the bloodstream of the attack rate acquired in the ICU compared dissemination of simple recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted to reanimation department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted to reanimation department\n\nExclusion Criteria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02891902', 'acronym': 'BacterHy', 'briefTitle': 'Impact of Dedicated Hygienist Staff on the Occurrence of Intensive Care Unit -Aquired Bloodstream Infections', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Impact of Dedicated Hygienist Staff on the Occurrence of Intensive Care Unit -Aquired Bloodstream Infections', 'orgStudyIdInfo': {'id': 'RC12_3682'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hygienist response', 'type': 'OTHER', 'description': 'The daily presence of a public health nurse in the intensive care unit would implement such a strategy for prevention of infections and reduce the incidence of bloodstream infections acquired in intensive care.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Urielle DESALBRES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}