Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-31 @ 2:31 PM
Study NCT ID:
NCT00425893
Status:
COMPLETED
Last Update Posted:
2012-04-13
First Post:
2007-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063373', 'term': 'Hand Hygiene'}, {'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D006920', 'term': 'Hygiene'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6069}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-12', 'studyFirstSubmitDate': '2007-01-19', 'studyFirstSubmitQcDate': '2007-01-22', 'lastUpdatePostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'secondary influenza infection', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['influenza', 'masks', 'transmission', 'hand hygiene', 'non-pharmacologic interventions'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '19652172', 'type': 'DERIVED', 'citation': 'Cowling BJ, Chan KH, Fang VJ, Cheng CK, Fung RO, Wai W, Sin J, Seto WH, Yung R, Chu DW, Chiu BC, Lee PW, Chiu MC, Lee HC, Uyeki TM, Houck PM, Peiris JS, Leung GM. Facemasks and hand hygiene to prevent influenza transmission in households: a cluster randomized trial. Ann Intern Med. 2009 Oct 6;151(7):437-46. doi: 10.7326/0003-4819-151-7-200910060-00142. Epub 2009 Aug 3.'}, {'pmid': '18461182', 'type': 'DERIVED', 'citation': 'Cowling BJ, Fung RO, Cheng CK, Fang VJ, Chan KH, Seto WH, Yung R, Chiu B, Lee P, Uyeki TM, Houck PM, Peiris JS, Leung GM. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households. PLoS One. 2008 May 7;3(5):e2101. doi: 10.1371/journal.pone.0002101.'}]}, 'descriptionModule': {'briefSummary': 'This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households', 'detailedDescription': 'Randomised controlled trial of surgical masks and alcohol hand wash among approximately 6069 Hong Kong residents who have a household member diagnosed with influenza. Influenza in index member and secondary infection will be documented with rapid influenza tests and PCR. Minimal risk to participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Member of family with influenza infected member\n\nExclusion Criteria:\n\n* Age less than 2 yr'}, 'identificationModule': {'nctId': 'NCT00425893', 'briefTitle': 'A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households', 'orgStudyIdInfo': {'id': 'CDC-NCCID-UCI000439A'}, 'secondaryIdInfos': [{'id': 'CDC Grant# 1 U01 CI000439-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'health education', 'interventionNames': ['Other: health education']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'hand hygiene', 'interventionNames': ['Behavioral: hand hygiene']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'masks and hand hygiene', 'interventionNames': ['Behavioral: hand hygiene', 'Device: face masks']}], 'interventions': [{'name': 'hand hygiene', 'type': 'BEHAVIORAL', 'description': 'alcohol-based hand wash', 'armGroupLabels': ['2', '3']}, {'name': 'health education', 'type': 'OTHER', 'description': 'Proper nutrition, etc.', 'armGroupLabels': ['1']}, {'name': 'face masks', 'type': 'DEVICE', 'description': 'face masks', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Benjamin J Cowling, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'The University of Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Peter Houck, MD', 'oldOrganization': 'CDC'}}}}