Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-02 @ 1:13 PM
Study NCT ID:
NCT03456635
Status:
SUSPENDED
Last Update Posted:
2022-01-20
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'unblinded'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'quasi-experimental study Time-series analysis, with a non-equivalent variable prospective Quality Improvement project'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}}, 'statusModule': {'whyStopped': 'Due to COVID', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequacy rate of surgical antimicrobial prophylaxis', 'timeFrame': 'baseline & 1 year', 'description': 'Adequacy rate of surgical antimicrobial prophylaxis according to the internal guidelines'}], 'secondaryOutcomes': [{'measure': 'Incidence of surgical site infections', 'timeFrame': 'baseline & 1 year', 'description': 'Incidence of surgical site infections in subgroups: hip \\& knee, colon \\& rectum, lumbar neurosurgeries and heart surgeries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antimicrobial', 'prophylaxys', 'CDSS'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of using a computerized decision program on the adequacy of the perioperative antimicrobial prophylaxis', 'detailedDescription': 'Adequacy rate of surgical antimicrobial prophylaxis, helped by a computerized decision support system, according to the internal guidelines considering the aspects: drug choice, dosing, timing, and re-dosing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All elective \\& emergency surgeries done by neurosurgery, orthopaedics, cardiovascular and digestive specialties made at University Hospitals of Geneva\n\nExclusion Criteria:\n\n* Patients \\< 40 kgs'}, 'identificationModule': {'nctId': 'NCT03456635', 'acronym': 'eSATP', 'briefTitle': 'Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System', 'orgStudyIdInfo': {'id': '2016-01881'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'usual antimicrobial prophylaxys', 'description': 'standard of care: perioperative antimicrobial prophylaxis without computerized decision support system'}, {'type': 'EXPERIMENTAL', 'label': 'guided antimicrobial prophylaxis', 'description': 'perioperative antimicrobial prophylaxis guided by a computerized decision support system', 'interventionNames': ['Other: guided antimicrobial prophylaxis']}], 'interventions': [{'name': 'guided antimicrobial prophylaxis', 'type': 'OTHER', 'description': 'During the intervention period, antimicrobial prophylaxis decisions will be guided by a computerized program', 'armGroupLabels': ['guided antimicrobial prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Americo Agostinho, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical nurse specialist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade do Porto', 'class': 'OTHER'}, {'name': 'University of Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Nurse Specialist', 'investigatorFullName': 'Américo Agostinho', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}