Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)
NCT ID: NCT01579370
Last Updated: 2015-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21395 participants
INTERVENTIONAL
2012-04-30
2015-08-31
Brief Summary
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Detailed Description
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Enhanced environmental disinfection methods may lead to reduced risk of exposure to or acquisition of HAIs and MDR-pathogens and overcome a critical issue facing healthcare today - hospitals rooms are often poorly cleaned and disinfected. Enhanced terminal room disinfection strategies using bleach and/or UV-C emitting devices have been investigated only in experimental conditions; the efficacy, effectiveness, and feasibility of enhanced terminal room disinfection to prevent HAIs are unknown. Thus, the scientific evidence for such interventions currently is insufficient for their inclusion in evidence-based guidelines.
This study will investigate the hypothesis that enhanced terminal room disinfection protocols (using chlorine-based cleaning agents with or without UV-C light-emitting devices) will decrease the overall risk of HAIs in the hospital and, more specifically, in subsequent patients who are cared for in the same room. This prospective investigation will employ a crossover design utilizing four room cleaning/disinfection protocols in 9 hospitals, including 2 tertiary care, 1 VA, and 6 community hospitals. Phase T2 data from this study will be useful in assessing the clinical efficacy and feasibility of individual disinfection strategies. Thus, the goals of the investigators proposed research are to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Quaternary ammonium
Rooms will be terminally cleaned using quaternary ammonium-containing compounds, the reference standard for hospital cleaning in US hospitals.
Quaternary ammonium
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
Bleach
Rooms will be terminally cleaned using bleach-containing products.
Bleach
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
Quaternary ammonium and UV-C light
Rooms will be terminally cleaned with quaternary ammonium-containing solutions followed by irradiation by a UV-C light emitting device.
Quaternary ammonium and UV-C light
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.
Bleach and UV-C light
Rooms will be terminally cleaned with bleach-containing solutions followed by irradiation by a UV-C light emitting device.
Bleach and UV-C light
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.
Interventions
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Quaternary ammonium
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
Bleach
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
Quaternary ammonium and UV-C light
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.
Bleach and UV-C light
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient outcomes will be excluded if clinical cultures are obtained within 48 hours of admission to the room of interest.
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Daniel J Sexton, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Alamance Regional Medical Center
Burlington, North Carolina, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Durham Regional Hospital
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Durham VA Medical Center
Durham, North Carolina, United States
High Point Regional Health System
High Point, North Carolina, United States
Rex Healthcare
Raleigh, North Carolina, United States
Duke Raleigh Hospital
Raleigh, North Carolina, United States
Chesapeake Regional Medical Center
Chesapeake, Virginia, United States
Countries
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References
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Rutala WA, Kanamori H, Gergen MF, Knelson LP, Sickbert-Bennett EE, Chen LF, Anderson DJ, Sexton DJ, Weber DJ; and the CDC Prevention Epicenters Program. Enhanced disinfection leads to reduction of microbial contamination and a decrease in patient colonization and infection. Infect Control Hosp Epidemiol. 2018 Sep;39(9):1118-1121. doi: 10.1017/ice.2018.165. Epub 2018 Jul 31.
Anderson DJ, Moehring RW, Weber DJ, Lewis SS, Chen LF, Schwab JC, Becherer P, Blocker M, Triplett PF, Knelson LP, Lokhnygina Y, Rutala WA, Sexton DJ; CDC Prevention Epicenters Program. Effectiveness of targeted enhanced terminal room disinfection on hospital-wide acquisition and infection with multidrug-resistant organisms and Clostridium difficile: a secondary analysis of a multicentre cluster randomised controlled trial with crossover design (BETR Disinfection). Lancet Infect Dis. 2018 Aug;18(8):845-853. doi: 10.1016/S1473-3099(18)30278-0. Epub 2018 Jun 4.
Anderson DJ, Knelson LP, Moehring RW, Lewis SS, Weber DJ, Chen LF, Triplett PF, Blocker M, Cooney RM, Schwab JC, Lokhnygina Y, Rutala WA, Sexton DJ; CDC Prevention Epicenters Program. Implementation Lessons Learned From the Benefits of Enhanced Terminal Room (BETR) Disinfection Study: Process and Perceptions of Enhanced Disinfection with Ultraviolet Disinfection Devices. Infect Control Hosp Epidemiol. 2018 Feb;39(2):157-163. doi: 10.1017/ice.2017.268. Epub 2018 Jan 14.
Anderson DJ, Chen LF, Weber DJ, Moehring RW, Lewis SS, Triplett PF, Blocker M, Becherer P, Schwab JC, Knelson LP, Lokhnygina Y, Rutala WA, Kanamori H, Gergen MF, Sexton DJ; CDC Prevention Epicenters Program. Enhanced terminal room disinfection and acquisition and infection caused by multidrug-resistant organisms and Clostridium difficile (the Benefits of Enhanced Terminal Room Disinfection study): a cluster-randomised, multicentre, crossover study. Lancet. 2017 Feb 25;389(10071):805-814. doi: 10.1016/S0140-6736(16)31588-4. Epub 2017 Jan 17.
Other Identifiers
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Pro00032718
Identifier Type: -
Identifier Source: org_study_id