Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-05 @ 2:43 AM
Study NCT ID:
NCT01671358
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Bacterial Contamination Rates Between Isolation and Non-isolation Rooms
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': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-20', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Presence of other bacterial colonization', 'timeFrame': 'Hospital stay, an expected average of 14 days', 'description': 'Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will be categorized as gram negative, gram positive catalase negative, Gram positive coagulase negative Staphylococcus species or methicillin-sensitive Staphylococcus aureus. This will serve as a baseline epidemiology of the hospital and generate other possible hypotheses.'}, {'measure': 'Correlation between MRSA and active infection or colonization of patient', 'timeFrame': 'Hospital stay, an expected average of 14 days', 'description': 'The patient from the same time frame in the rooms sampled and positive for MRSA colonization will be reviewed to determine if they had active infection or were previously colonized.'}, {'measure': 'Correlation between colonization of other positive organisms and active infection or colonization of patient', 'timeFrame': 'Hospital stay, an expected average of 14 days', 'description': 'The patient from the same time frame in the rooms sampled and positive for non-MRSA colonization will be reviewed to determine if they had active infection or were previously colonized.'}], 'primaryOutcomes': [{'measure': 'Presence of MRSA colonization', 'timeFrame': 'Hospital stay, an expected average of 14 days', 'description': 'Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will then be run through standard identification tests to determine if the colonies are MRSA or not. A comparison will be made between non-isolation and isolation rooms.'}], 'secondaryOutcomes': [{'measure': 'Quantification of MRSA colonization', 'timeFrame': 'Hospital stay, an expected average of 14 days', 'description': 'Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. A comparison between the sites of swabbing will be performed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRSA', 'Contamination', 'Isolation'], 'conditions': ['Methicillin-Resistant Staphylococcus Aureus']}, 'referencesModule': {'references': [{'pmid': '11114617', 'type': 'BACKGROUND', 'citation': 'Bures S, Fishbain JT, Uyehara CF, Parker JM, Berg BW. Computer keyboards and faucet handles as reservoirs of nosocomial pathogens in the intensive care unit. Am J Infect Control. 2000 Dec;28(6):465-71. doi: 10.1067/mic.2000.107267.'}, {'pmid': '16290319', 'type': 'BACKGROUND', 'citation': "Sexton T, Clarke P, O'Neill E, Dillane T, Humphreys H. Environmental reservoirs of methicillin-resistant Staphylococcus aureus in isolation rooms: correlation with patient isolates and implications for hospital hygiene. J Hosp Infect. 2006 Feb;62(2):187-94. doi: 10.1016/j.jhin.2005.07.017. Epub 2005 Nov 14."}, {'pmid': '12090803', 'type': 'BACKGROUND', 'citation': 'Oie S, Hosokawa I, Kamiya A. Contamination of room door handles by methicillin-sensitive/methicillin-resistant Staphylococcus aureus. J Hosp Infect. 2002 Jun;51(2):140-3. doi: 10.1053/jhin.2002.1221.'}, {'pmid': '17030826', 'type': 'BACKGROUND', 'citation': 'Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51. doi: 10.1001/archinte.166.18.1945.'}, {'pmid': '17080391', 'type': 'BACKGROUND', 'citation': 'Huang R, Mehta S, Weed D, Price CS. Methicillin-resistant Staphylococcus aureus survival on hospital fomites. Infect Control Hosp Epidemiol. 2006 Nov;27(11):1267-9. doi: 10.1086/507965. Epub 2006 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'This study is to determine if medication cabinets located outside of isolation rooms in hospitals and their contents, particularly medications and the delivery folders are at a higher risk of having harmful bacteria on them.', 'detailedDescription': 'Studies show high touch areas maybe contaminated with organisms such as Methicillin-resistant Staphylococcus aureus(MRSA) and vancomycin-resistant enterococci. MRSA can live on hospital surfaces for 9-14 days. Patients in rooms that were previously MRSA isolation rooms are at higher risk for developing a hospital-acquired infection.\n\nThis study is to determine if medication cabinets located outside of MRSA isolation rooms and their contents, particularly medications and the pharmacy delivery folders are at a higher risk of having MRSA colonization on them. This study will use conventional methods to determine if MRSA colonization is present and compare results between non-isolation and isolation rooms. This will evaluate if alternate measures for the reduction of MRSA colonization are needed for the MRSA isolation rooms in regards to medication delivery and storage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inaptients at an academic medical center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient rooms with isolation status for MRSA\n* Patient rooms without isolation status for MRSA for 14 days\n\nExclusion Criteria:\n\n* Rooms without medication cabinets directly outside the room'}, 'identificationModule': {'nctId': 'NCT01671358', 'briefTitle': 'Comparison of Bacterial Contamination Rates Between Isolation and Non-isolation Rooms', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Comparison of Contamination Rates of Medication Storage Cabinets Between Isolation and Non-isolation Rooms With Methicillin-resistant Staphylococcus Aureus (MRSA)', 'orgStudyIdInfo': {'id': 'WVU-00010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isolation Rooms for MRSA', 'description': 'Rooms that currently have a patient in them that are in isolation status due to MRSA'}, {'label': 'Non-isolation rooms', 'description': 'Rooms that have not been occupied by a patient in isolation due to MRSA for 14 days'}]}, 'contactsLocationsModule': {'locations': [{'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Hospitals', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacy Clinical Specialist - Quality Outcomes', 'investigatorFullName': 'Michael Sweet', 'investigatorAffiliation': 'West Virginia University'}}}}