Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-31 @ 11:05 PM
Study NCT ID:
NCT00846105
Status:
COMPLETED
Last Update Posted:
2010-06-15
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Rapid Test to Prevent Hospital Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-14', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2010-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if a ≥ 50 % reduction of incidence of nosocomial MRSA acquisition can be observed after replacing culture by PCR for universal MRSA screening of patients upon admission to high incidence units in two acute care hospitals', 'timeFrame': '5-10 months'}], 'secondaryOutcomes': [{'measure': 'Median time required for detection of MRSA carriage after admission', 'timeFrame': '5-10 months'}, {'measure': 'Median time required for starting isolation of MRSA carriers', 'timeFrame': '5-10 months'}, {'measure': 'Number of patient-days of MRSA carrier stay in non-isolated conditions', 'timeFrame': '5-10 months'}, {'measure': 'MRSA nosocomial infection rate', 'timeFrame': '5-10 months'}, {'measure': 'MRSA cross-transmission rate', 'timeFrame': '5-10 months'}, {'measure': 'Sensitivity and specificity of PCR vs conventional MRSA screening by culture', 'timeFrame': '10 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['methicillin resistant Staphylococcus aureus', 'MRSA', 'cross-infection', 'staphylococcal infection', 'infection control'], 'conditions': ['Methicillin Resistance', 'Staphylococcus Aureus', 'Staphylococcal Infection']}, 'referencesModule': {'references': [{'pmid': '16563177', 'type': 'BACKGROUND', 'citation': 'Struelens MJ, Denis O. Rapid molecular detection of methicillin-resistant Staphylococcus aureus: a cost-effective tool for infection control in critical care? Crit Care. 2006;10(2):128. doi: 10.1186/cc4855.'}, {'pmid': '24836438', 'type': 'DERIVED', 'citation': 'Roisin S, Laurent C, Denis O, Dramaix M, Nonhoff C, Hallin M, Byl B, Struelens MJ. Impact of rapid molecular screening at hospital admission on nosocomial transmission of methicillin-resistant Staphylococcus aureus: cluster randomised trial. PLoS One. 2014 May 16;9(5):e96310. doi: 10.1371/journal.pone.0096310. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of a novel PCR-based laboratory test for rapid detection of MRSA carriers to prevent transmission of MRSA in the Belgian acute care hospital setting.', 'detailedDescription': 'Methicillin-resistant Staphylococcus aureus (MRSA) strains have become endemic pathogens in acute and chronic healthcare facilities in Belgium. MRSA infection is causing increased public concern as it carries a significant risk of morbidity, mortality and has been linked to substantial excess healthcare costs.\n\nEfficient control of MRSA transmission within healthcare facilities critically depends on screening for and isolation of MRSA carriers among admitted patients. Active surveillance cultures for MRSA are now part of clinical practice recommendations both in Europe and the USA. Indeed, studies have indicated that up to 70 % of the patient reservoir for MRSA among hospitalized patients can only be detected by active sampling of muco-cutaneous colonization sites. There is an urgent public health need for early and reliable detection of carriers of MRSA among patients admitted to healthcare facilities, to inform patient isolation and decontamination procedures, and thereby more effectively control cross-infection\n\nThe general objectives of this intervention study to be conducted in two large Belgian hospitals are to measure the impact of rapid (\\< 3 h) PCR detection of MRSA carriage upon patient admission on shortening the delay to implement contact isolation precautions for carriers and reducing nosocomial MRSA transmission to patients admitted in the same wards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted for more than 48h to a ward in which evaluation in the previous baseline period met the following:\n\n * \\> 80 % compliance with admission and discharge conventional culture screening, for the pooled admissions to all study wards;\n * \\> 80 % compliance with additional MRSA contact isolation procedures, based on a sample of 50 patient care contact observations per hospital in all study wards;\n * pooled incidence of nosocomial MRSA acquisition ≥ 1.5 new cases /100 at risk admissions in the study wards.\n\nExclusion Criteria:\n\n* Patients staying 48h or less in the study wards'}, 'identificationModule': {'nctId': 'NCT00846105', 'briefTitle': 'Efficacy Study of Rapid Test to Prevent Hospital Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA)', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Two-Center Intervention Study to Evaluate the Impact of Rapid Molecular Screening on Nosocomial Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA).', 'orgStudyIdInfo': {'id': 'Erasme-ULB-P2008/201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapid PCR screen', 'description': 'Rapid PCR screen test for detection of MRSA carriers upon hospital admission', 'interventionNames': ['Other: Rapid MRSA PCR test for screening carriers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional culture', 'description': 'Conventional culture screen for detection of MRSA carriers upon hospital admission', 'interventionNames': ['Other: Rapid MRSA PCR test for screening carriers']}], 'interventions': [{'name': 'Rapid MRSA PCR test for screening carriers', 'type': 'OTHER', 'otherNames': ['GeneXpert MRSA, Cepheid.', 'Real-time PCR assay for MRSA'], 'description': "In the rapid test intervention arm, all patients admitted to study wards will be sampled within 24 h after admission. To ensure comparison of like with like, sample taking will include: (1) a swab from the anterior nares for PCR testing according to the test manufacturer's instructions; (2) the swab of anterior nares, and swabs from throat, perineum and of any wounds, bladder catheter or intravenous catheter exit site will be processed by conventional testing.", 'armGroupLabels': ['Conventional culture', 'Rapid PCR screen']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Sint-Jan AV', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'ULB Hopital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Marc J Struelens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasme University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Marc J. Struelens', 'oldOrganization': 'Erasme University Hospital'}}}}