NCT05973916

Brief Summary

A comprehensive intervention to improve the level of cleaning and disinfection of patients' units, in order to reduce new acquisitions and environmental contamination by multidrug resistant organisms: a prospective controlled crossover trial, using VYV led lights and continuous air filtering of patients' rooms, coupled with establishment of a "patient's unit commando" cleaning team.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

July 26, 2023

Last Update Submit

July 30, 2024

Conditions

Hospital Acquired Condition

Outcome Measures

Primary Outcomes (1)

  • Acquisitions of pre-specified MDROs:

    Incidence of MDRO new carriage acquisitions (per 1,000 patient-days).

    6 months

Secondary Outcomes (2)

  • Acquisitions of hospital acquired bloodstream infection

    6 months

  • Acquisitions of ospital acquired urinary-tract infection (HAUTI) incidence (per 1,000 patient-days).

    6 months

Study Arms (2)

Comprehensive intervention

EXPERIMENTAL

Cleaning of patients' rooms will be subjected to a comprehensive intervention, consisting of: 1) a "patient's unit commando" team for daily and for terminal cleaning, 2) all lights in patients' room are VYV led lights, and 3) in each room, a QleanAir Scandinavia® filtering machine will be placed.

Other: Comprehensive intervention

Common Practice

NO INTERVENTION

Patients' rooms will be cleaned and disinfected according to the current "common practice" as detailed below.

Interventions

Comprehensive interventionOTHER

cleaning of patients' rooms will be subjected to a comprehensive intervention, consisting of: 1) a "patient's unit commando" team for daily and for terminal cleaning, 2) all lights in patients' room are VYV led lights, and 3) in each room, a QleanAir Scandinavia® filtering machine will be placed.

Also known as: VYV led lights, Patient's unit commando, QleanAir Scandinavia® filtering machine
Comprehensive intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized at Medicine A or Medicine B, Shamir (Assaf Harofeh) Medical Center.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, 70300, Israel

RECRUITING

Related Publications (11)

  • Turner RM, White IR, Croudace T; PIP Study Group. Analysis of cluster randomized cross-over trial data: a comparison of methods. Stat Med. 2007 Jan 30;26(2):274-89. doi: 10.1002/sim.2537.

    PMID: 16538700BACKGROUND

  • Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.

    PMID: 18538699BACKGROUND

  • Han JH, Sullivan N, Leas BF, Pegues DA, Kaczmarek JL, Umscheid CA. Cleaning Hospital Room Surfaces to Prevent Health Care-Associated Infections: A Technical Brief. Ann Intern Med. 2015 Oct 20;163(8):598-607. doi: 10.7326/M15-1192. Epub 2015 Aug 11.

    PMID: 26258903BACKGROUND

  • Tanner WD, Leecaster MK, Zhang Y, Stratford KM, Mayer J, Visnovsky LD, Alhmidi H, Cadnum JL, Jencson AL, Koganti S, Bennett CP, Donskey CJ, Noble-Wang J, Reddy SC, Rose LJ, Watson L, Ide E, Wipperfurth T, Safdar N, Arasim M, Macke C, Roman P, Krein SL, Loc-Carrillo C, Samore MH. Environmental Contamination of Contact Precaution and Non-Contact Precaution Patient Rooms in Six Acute Care Facilities. Clin Infect Dis. 2021 Jan 29;72(Suppl 1):S8-S16. doi: 10.1093/cid/ciaa1602.

    PMID: 33512527BACKGROUND

  • Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24. doi: 10.1111/j.1574-695X.2003.tb00644.x.

    PMID: 12589953BACKGROUND

  • Manoukian S, Stewart S, Graves N, Mason H, Robertson C, Kennedy S, Pan J, Haahr L, Dancer SJ, Cook B, Reilly J. Evaluating the post-discharge cost of healthcare-associated infection in NHS Scotland. J Hosp Infect. 2021 Aug;114:51-58. doi: 10.1016/j.jhin.2020.12.026.

    PMID: 34301396BACKGROUND

  • Maclean M, MacGregor SJ, Anderson JG, Woolsey G. Inactivation of bacterial pathogens following exposure to light from a 405-nanometer light-emitting diode array. Appl Environ Microbiol. 2009 Apr;75(7):1932-7. doi: 10.1128/AEM.01892-08. Epub 2009 Feb 6.

    PMID: 19201962BACKGROUND

  • Wolkewitz M, Barnett AG, Palomar Martinez M, Frank U, Schumacher M; IMPLEMENT Study Group. Interventions to control nosocomial infections: study designs and statistical issues. J Hosp Infect. 2014 Feb;86(2):77-82. doi: 10.1016/j.jhin.2013.09.015. Epub 2013 Oct 18.

    PMID: 24286854BACKGROUND

  • Boyce JM. Modern technologies for improving cleaning and disinfection of environmental surfaces in hospitals. Antimicrob Resist Infect Control. 2016 Apr 11;5:10. doi: 10.1186/s13756-016-0111-x. eCollection 2016.

    PMID: 27069623BACKGROUND

  • Weber DJ, Rutala WA, Miller MB, Huslage K, Sickbert-Bennett E. Role of hospital surfaces in the transmission of emerging health care-associated pathogens: norovirus, Clostridium difficile, and Acinetobacter species. Am J Infect Control. 2010 Jun;38(5 Suppl 1):S25-33. doi: 10.1016/j.ajic.2010.04.196.

    PMID: 20569853BACKGROUND

  • McKenzie K, Maclean M, Grant MH, Ramakrishnan P, MacGregor SJ, Anderson JG. The effects of 405 nm light on bacterial membrane integrity determined by salt and bile tolerance assays, leakage of UV-absorbing material and SYTOX green labelling. Microbiology (Reading). 2016 Sep;162(9):1680-1688. doi: 10.1099/mic.0.000350. Epub 2016 Aug 5.

    PMID: 27499074BACKGROUND

MeSH Terms

Conditions

Iatrogenic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dror Marchaim, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Marchaim, MD

CONTACT

+97289778146drormarchaim@shamir.gov.il

Ron Finkenberg

CONTACT

+97289778248ronfin@shamir.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Unit of Infection Control & Prevention

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 3, 2023

Study Start

August 3, 2023

Primary Completion

February 2, 2025

Study Completion

August 3, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)