Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-04 @ 12:24 AM
Study NCT ID:
NCT00685867
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2008-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Strategies for Methicillin-resistant Staphylococcus Aureus (MRSA) Infection Prevention in Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-20', 'studyFirstSubmitDate': '2008-05-27', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nosocomial MRSA isolation rate (expressed as the monthly rate of MRSA in clinical isolates divided by the number of susceptible patients per hundred)', 'timeFrame': 'Monthly'}], 'secondaryOutcomes': [{'measure': 'Nosocomial MRSA infection rate (= number of nosocomial MRSA infections per 100 admissions)', 'timeFrame': 'Monthly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Staphylococcus aureus', 'Resistance', 'Prevention'], 'conditions': ['MRSA Infection']}, 'referencesModule': {'references': [{'pmid': '24056477', 'type': 'DERIVED', 'citation': 'Lee AS, Cooper BS, Malhotra-Kumar S, Chalfine A, Daikos GL, Fankhauser C, Carevic B, Lemmen S, Martinez JA, Masuet-Aumatell C, Pan A, Phillips G, Rubinovitch B, Goossens H, Brun-Buisson C, Harbarth S; MOSAR WP4 Study Group. Comparison of strategies to reduce meticillin-resistant Staphylococcus aureus rates in surgical patients: a controlled multicentre intervention trial. BMJ Open. 2013 Sep 19;3(9):e003126. doi: 10.1136/bmjopen-2013-003126.'}]}, 'descriptionModule': {'briefSummary': 'The study is a two-arm controlled multi-centre trial of two strategies to reduce nosocomial MRSA transmission and infection among surgical patients. Enrolment and primary analyses will be performed at the hospital level. A total of ten adult surgical departments with at least 3 surgical subspecialties each will participate in the study. Sites of the study are located in 9 countries (UK, France, Spain, Germany, Switzerland, Italy, Serbia, Greece and Israel).\n\nThe primary objective is to determine the effect of an early MRSA detection \\& decolonization \\& isolation strategy compared to an enhanced standard control strategy on healthcare-associated MRSA isolation rates among surgical patients at risk of MRSA carriage, who are hospitalized for at least 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical patients with LOS\\>24h\n\nExclusion Criteria:\n\n* Surgical patients with LOS\\<24h'}, 'identificationModule': {'nctId': 'NCT00685867', 'acronym': 'MOSAR-04', 'briefTitle': 'Two Strategies for Methicillin-resistant Staphylococcus Aureus (MRSA) Infection Prevention in Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'An Interventional Study to Evaluate the Impact of Two Innovative Strategies in Preventing Nosocomial MRSA Infection in Surgical Patients', 'orgStudyIdInfo': {'id': 'LSHP-CT-037940'}, 'secondaryIdInfos': [{'id': 'LSHP-CT-037940'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Rapid detection', 'interventionNames': ['Other: Rapid molecular MRSA test']}, {'type': 'OTHER', 'label': '2', 'description': 'Enhanced infection control', 'interventionNames': ['Behavioral: Hand hygiene promotion']}], 'interventions': [{'name': 'Rapid molecular MRSA test', 'type': 'OTHER', 'description': 'PCR-based rapid screening for MRSA carriage', 'armGroupLabels': ['1']}, {'name': 'Hand hygiene promotion', 'type': 'BEHAVIORAL', 'description': "* Promotion and monitoring of hand hygiene, with special emphasis on alcohol-based hand rubs and feedback of hand hygiene compliance\n* Standard precautions (e.g. use of gloves for contacts with wounds and body fluids)\n* Isolation precautions according to the hospitals' capacity and strategy\n* Additional basic infection control interventions (if necessary)", 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stephen Harbarth', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}