Multidrug Resistant OrganismsNCT01579370

Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)

A study testing Quaternary ammonium, Bleach and Quaternary ammonium and UV-C light in people with Multidrug Resistant Organisms and Healthcare Associated Infections, run by Duke University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Multidrug Resistant Organisms, Healthcare Associated Infections
What is being tested?: Quaternary ammonium, Bleach and Quaternary ammonium and UV-C light
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21,395 participants
Where: 9 sitesUnited States
Study dates: Apr 2012to Aug 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Any seed room (ie., room from which a patient with one of the target organisms has been transferred or discharged)

Who cannot join

None, intervention is at level of the room, not the patient
Patient outcomes will be excluded if clinical cultures are obtained within 48 hours of admission to the room of interest.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Alamance Regional Medical Center
Burlington, North Carolina, 27215
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514
Chesapeake Regional Medical Center
Chesapeake, Virginia, 23320
Durham Regional Hospital
Durham, North Carolina, 27704
Duke University Medical Center
Durham, North Carolina, 27710
Durham VA Medical Center
Durham, North Carolina, 27710
High Point Regional Health System
High Point, North Carolina, 27261
Rex Healthcare
Raleigh, North Carolina, 27607
Duke Raleigh Hospital
Raleigh, North Carolina, 27609

Other trials in United States

About this study

Official title: A Four-arm Prospective, Multicenter Study to Assess the Efficacy, Effectiveness, and Feasibility of Enhanced Terminal Room Disinfection With Chlorine and UV Light Using Clinical and Microbiologic Outcomes

Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter study enhanced terminal room disinfection 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.

Read the detailed description

Meticulous and consistent use of hand hygiene before and after patient care remains the cornerstone of infection prevention in all health care settings. However, clean hands are not sufficient to prevent all healthcare-associated infections (HAIs), as 1) hands of healthcare workers easily become contaminated from contact with contaminated environmental surfaces in patient rooms after appropriate hand hygiene has been performed and before direct patient care and 2) direct contact by patients with preexisting contaminated environmental surfaces in their hospital rooms can lead to colonization or infection. Thus, novel strategies are needed to prevent HAIs, particularly those caused by multidrug-resistant (MDR) pathogens that persist in the environment such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), Clostridium difficile, and Acinetobacter.

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: Multidrug Resistant Organisms, Healthcare Associated Infections
Being tested: Quaternary ammonium, Bleach, Quaternary ammonium and UV-C light, Bleach and UV-C light
Keywords: healthcare associated infections, multidrug resistant organisms, methicillin resistant staphylococcus aureus, vancomycin resistant enterococcus, clostridium difficile, acinetobacter
Medical subject headings: Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quaternary ammoniumOther
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.
BleachOther
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 lightOther
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 lightOther
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.

Study groups in NCT01579370
Study group	Role	What they receive
Quaternary ammonium	Active comparator	Rooms will be terminally cleaned using quaternary ammonium-containing compounds, the reference standard for hospital cleaning in US hospitals. Receives: Other: Quaternary ammonium
Bleach	Experimental	Rooms will be terminally cleaned using bleach-containing products. Receives: Other: Bleach
Quaternary ammonium and UV-C light	Experimental	Rooms will be terminally cleaned with quaternary ammonium-containing solutions followed by irradiation by a UV-C light emitting device. Receives: Other: Quaternary ammonium and UV-C light
Bleach and UV-C light	Experimental	Rooms will be terminally cleaned with bleach-containing solutions followed by irradiation by a UV-C light emitting device. Receives: Other: Bleach and UV-C light

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical incidence rate of four target organisms among patients admitted to a study room
Patients will be monitored for clinical cultures that grow one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) following admission to a "seed" room. Cultures for vegetative bacteria (MRSA, VRE, Acinetobacter) will be included if obtained within 90 days of discharge from a seed room; cultures for C. difficile will be included if they are obtained within 28 days of discharge from a seed room.
Measured: 90 days
Clinical incidence rate of C. difficile among patients admitted to a study room
Patients will be monitored for clinical cultures that grow C. difficile following admission to a "seed" room.
Measured: 28 days

Secondary outcomes (19)

Clinical incidence rate of target vegetative bacteria (MRSA, VRE, Acinetobacter) among patients admitted to a seed room.
Patients will be monitored for clinical cultures that grow one of three target vegetative organisms (MRSA, VRE, and MDR-Acinetobacter) following admission to a "seed" room.
Measured: 90 days
Clinical incidence rate of target organisms among all patients admitted to the hospital
All hospitalized patients will be monitored for clinical cultures that grow one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) regardless of exposure to seed room.
Measured: 90 days
Clinical incidence rate of MRSA among all patients admitted to the hospital
All hospitalized patients will be monitored for clinical cultures that grow MRSA regardless of exposure to seed room.
Measured: 90 days
Clinical incidence rate of VRE among all patients admitted to the hospital
All hospitalized patients will be monitored for clinical cultures that grow VRE regardless of exposure to seed room.
Measured: 90 days
Clinical incidence rate of MDR-Acinetobacter among all patients admitted to the hospital
All hospitalized patients will be monitored for clinical cultures that grow MDR-Acinetobacter regardless of exposure to seed room.
Measured: 90 days
Clinical incidence rate of C. difficile among all patients admitted to the hospital
All hospitalized patients will be monitored for clinical cultures that grow C. difficile regardless of exposure to seed room.
Measured: 28 days
Incidence rate of healthcare-associated infections caused by target bacteria (MRSA, VRE, C. difficile, and MDR-Acinetobacter) among patients admitted to a seed room.
Patients will be monitored for HAIs due to one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) following admission to a "seed" room. NHSN definitions for HAIs will be used.
Measured: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by MRSA among patients admitted to a seed room.
Patients will be monitored for HAIs due to MRSA following admission to a "seed" room. NHSN definitions for HAIs will be used.
Measured: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by VRE among patients admitted to a seed room.
Patients will be monitored for HAIs due to VRE following admission to a "seed" room. NHSN definitions for HAIs will be used.
Measured: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among patients admitted to a seed room.
Patients will be monitored for HAIs due to MDR-Acinetobacter following admission to a "seed" room. NHSN definitions for HAIs will be used.
Measured: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among all hospitalized patients.
Patients will be monitored for HAIs due to MDR-Acinetobacter, regardless of exposure to seed room. NHSN definitions for HAIs will be used.
Measured: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by MRSA among all hospitalized patients.
Patients will be monitored for HAIs due to MRSA, regardless of exposure to seed room. NHSN definitions for HAIs will be used.
Measured: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by VRE among all hospitalized patients.
Patients will be monitored for HAIs due to VRE, regardless of exposure to seed room. NHSN definitions for HAIs will be used.
Measured: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by target vegetative bacteria (MRSA, VRE, MDR-Acinetobacter) among all hospitalized patients.
Patients will be monitored for HAIs due to MRSA, VRE, and MDR-Acinetobacter regardless of exposure to seed room. NHSN definitions for HAIs will be used.
Measured: Patients will be followed an average of 30 days
Missed Opportunities
Use of UV-C emitting devices will be monitored and "missed opportunities" (ie, UV-C emitter should have been used per protocol and was not) will be tracked and summarized. This proportion will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) arm will be considered the reference group.
Measured: each study period (6 months)
Time on Diversion
Hospital data will be gathered to determine if use of UV-C emitting devices leads to downstream effects on hospital process. The proportion will be calculated as the average number of days on diversion per month for each study period. This proportion will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) will be considered the reference group.
Measured: Each study period (6 months)
Room Turnover Time
Room cleaning process will be monitored and tracked. We will obtain start and stop times for terminal room cleaning to determine if use of UV-C light emitting devices leads to additional time for room turnover. Average times will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) arm will be considered the reference group.
Measured: Each study period (6 months)
ED to floor wait time
Hospital data will be gathered to determine if use of UV-C emitting devices leads to downstream effects on hospital process. Average times will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) arm will be considered the reference group.
Measured: Each study period (6 months)
Clinical incidence of MRSA, VRE, C. difficile, and MDR-Acinetobacter during UV-C light versus No UV-C light
The clinical incidence rate of MRSA, VRE, C. difficile, and MDR-Acinetobacter will be calculated for the two 6-month study arms (12 months total) during which UV-C light is used for terminal room disinfection (regardless of which chemical is used) and compared to the two 6-month study arms (12 months total) during which UV-C light is not used for terminal room disinfection.
Measured: 12 months (2 6-month study arms combined)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Aug 2015

First posted18 Apr 2012 (estimated)
Study startApr 2012
Primary completionJul 2014
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Multidrug Resistant OrganismsStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 21,395 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01579370
Sponsor's protocol ID: Pro00032718
Other IDs: 1U54CK000164-01
Status last verified: Nov 2015
First submitted: 5 Apr 2012
Last updated: 17 Nov 2015
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 30060770
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.
PubMed 29880301
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.
PubMed 29331170
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.
PubMed 28104287

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Four-arm Prospective, Multicenter Study to Assess the Efficacy, Effectiveness, and Feasibility of Enhanced Terminal Room Disinfection With Chlorine and UV Light Using Clinical and Microbiologic Outcomes
ClinicalTrials.gov ID: NCT01579370
Acronym / sponsor ID: Pro00032718
Conditions: Multidrug Resistant Organisms, Healthcare Associated Infections
Keywords: healthcare associated infections, multidrug resistant organisms, methicillin resistant staphylococcus aureus, vancomycin resistant enterococcus, clostridium difficile, acinetobacter
Study type: Interventional
Recruitment status: Completed
Enrolment: 21,395 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Apr 2012
Primary completion: Jul 2014 (actual)
Study completion: Aug 2015 (actual)
First posted: 18 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Quaternary ammonium	Active comparator	Other: Quaternary ammoniumRooms will be terminally cleaned using quaternary ammonium-containing compounds, the reference standard for hospital cleaning in US hospitals.
Bleach	Experimental	Other: BleachRooms will be terminally cleaned using bleach-containing products.
Quaternary ammonium and UV-C light	Experimental	Other: Quaternary ammonium and UV-C lightRooms will be terminally cleaned with quaternary ammonium-containing solutions followed by irradiation by a UV-C light emitting device.
Bleach and UV-C light	Experimental	Other: Bleach and UV-C lightRooms will be terminally cleaned with bleach-containing solutions followed by irradiation by a UV-C light emitting device.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Any seed room (ie., room from which a patient with one of the target organisms has been transferred or discharged)

Key exclusion criteria (2 listed)

None, intervention is at level of the room, not the patient
Patient outcomes will be excluded if clinical cultures are obtained within 48 hours of admission to the room of interest.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quaternary ammoniumRooms 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.	Other	Quaternary ammonium
BleachRooms 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.	Other	Bleach
Quaternary ammonium and UV-C lightRooms 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.	Other	Quaternary ammonium and UV-C light
Bleach and UV-C lightRooms 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.	Other	Bleach and UV-C light

Primary outcome

Clinical incidence rate of four target organisms among patients admitted to a study room
Time frame: 90 days
Patients will be monitored for clinical cultures that grow one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) following admission to a "seed" room. Cultures for vegetative bacteria (MRSA, VRE, Acinetobacter) will be included if obtained within 90 days of discharge from a seed room; cultures for C. difficile will be included if they are obtained within 28 days of discharge from a seed room.
Clinical incidence rate of C. difficile among patients admitted to a study room
Time frame: 28 days
Patients will be monitored for clinical cultures that grow C. difficile following admission to a "seed" room.

19 secondary outcomes

Clinical incidence rate of target vegetative bacteria (MRSA, VRE, Acinetobacter) among patients admitted to a seed room.
Time frame: 90 days
Clinical incidence rate of target organisms among all patients admitted to the hospital
Time frame: 90 days
Clinical incidence rate of MRSA among all patients admitted to the hospital
Time frame: 90 days
Clinical incidence rate of VRE among all patients admitted to the hospital
Time frame: 90 days
Clinical incidence rate of MDR-Acinetobacter among all patients admitted to the hospital
Time frame: 90 days
Clinical incidence rate of C. difficile among all patients admitted to the hospital
Time frame: 28 days
Incidence rate of healthcare-associated infections caused by target bacteria (MRSA, VRE, C. difficile, and MDR-Acinetobacter) among patients admitted to a seed room.
Time frame: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by MRSA among patients admitted to a seed room.
Time frame: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by VRE among patients admitted to a seed room.
Time frame: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among patients admitted to a seed room.
Time frame: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among all hospitalized patients.
Time frame: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by MRSA among all hospitalized patients.
Time frame: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by VRE among all hospitalized patients.
Time frame: Patients will be followed an average of 30 days
Incidence rate of healthcare-associated infections caused by target vegetative bacteria (MRSA, VRE, MDR-Acinetobacter) among all hospitalized patients.
Time frame: Patients will be followed an average of 30 days
Missed Opportunities
Time frame: each study period (6 months)
Time on Diversion
Time frame: Each study period (6 months)
Room Turnover Time
Time frame: Each study period (6 months)
ED to floor wait time
Time frame: Each study period (6 months)
Clinical incidence of MRSA, VRE, C. difficile, and MDR-Acinetobacter during UV-C light versus No UV-C light
Time frame: 12 months (2 6-month study arms combined)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
Derived from this study: PubMed 30060770Rutala 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.
Derived from this study: PubMed 29880301Anderson 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.
Derived from this study: PubMed 29331170Anderson 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.
Derived from this study: PubMed 28104287Anderson 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel J Sexton, MD principal investigator

Duke University

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical incidence rate of four target organisms among patients admitted to a study room (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01579370, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.