NCT01579370

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,395

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

2.2 years

First QC Date

April 5, 2012

Last Update Submit

November 15, 2015

Conditions

Multidrug Resistant OrganismsHealthcare Associated Infections

Keywords

healthcare associated infectionsmultidrug resistant organismsmethicillin resistant staphylococcus aureusvancomycin resistant enterococcusclostridium difficileacinetobacter

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    28 days

Secondary Outcomes (19)

  • Clinical incidence rate of target vegetative bacteria (MRSA, VRE, Acinetobacter) among patients admitted to a seed room.

    90 days

  • Clinical incidence rate of target organisms among all patients admitted to the hospital

    90 days

  • Clinical incidence rate of MRSA among all patients admitted to the hospital

    90 days

  • Clinical incidence rate of VRE among all patients admitted to the hospital

    90 days

  • Clinical incidence rate of MDR-Acinetobacter among all patients admitted to the hospital

    90 days

  • +14 more secondary outcomes

Study Arms (4)

Quaternary ammonium

ACTIVE COMPARATOR

Rooms will be terminally cleaned using quaternary ammonium-containing compounds, the reference standard for hospital cleaning in US hospitals.

Other: Quaternary ammonium

Bleach

EXPERIMENTAL

Rooms will be terminally cleaned using bleach-containing products.

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.

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.

Other: Bleach and UV-C light

Interventions

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.

Quaternary ammonium
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.

Bleach
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.

Quaternary ammonium and UV-C light
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.

Bleach and UV-C light

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Alamance Regional Medical Center

Burlington, North Carolina, 27215, United States

Location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

Durham Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27710, United States

Location

High Point Regional Health System

High Point, North Carolina, 27261, United States

Location

Rex Healthcare

Raleigh, North Carolina, 27607, United States

Location

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States

Location

Chesapeake Regional Medical Center

Chesapeake, Virginia, 23320, United States

Location

Related Publications (4)

  • 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.

    PMID: 30060770DERIVED

  • 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.

    PMID: 29880301DERIVED

  • 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.

    PMID: 29331170DERIVED

  • 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.

    PMID: 28104287DERIVED

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel J Sexton, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 18, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2014

Study Completion

August 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(9)