Condition category
Infections and Infestations
Date applied
29/10/2018
Date assigned
19/11/2018
Last edited
05/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Methicillin-resistant Staphylococcus aureus (MRSA) can cause serious disease that can be difficult to treat because the bacteria cannot be killed by commonly used antibiotics. Patients can acquire MRSA while in hospital and can carry it into the community without showing signs of infection. Surfaces in hospital can be made to contain or can be treated with substances that kill bacteria continuously. This might be an effective way of controlling the spread of MRSA in hospitals. This study aims to investigate whether applying an antibacterial coating to surfaces in an intensice care unit (ICU) could reduce acquisition of MRSA and other disease-causing bacteria in the patients.

Who can participate?
All patients admitted to the medical ICU of Bundang Jesaeng Hospital during the study period were included, except patients aged under 18 years and patients in hospital for less than 72 hours.

What does the study involve?
For the first 5 months of the trial, patients were treated as usual except that the inside of their nostrils were swabbed within 48 hours of ICU admission and at discharge from hospital. A titanium dioxide coating was then applied to surfaces and walls in the ICU that were regularly touched by people. For the next 5 months, patients were again treated as usual except that the inside of their nostrils were swabbed within 48 hours of ICU admission and at discharge from hospital. The swabs were cultured in a laboratory to check for disease-causing bacteria, including MRSA.

What are the possible benefits and risks of participating?:
After the antibacterial coating had been applied, the participants might have a lower risk of acquiring disease-causing bacteria from the hospital environment. Otherwise, they were treated as normal, so there was no additional risk.

Where is the study run from?
The study was performed at Bundang Jesaeng Hospital, a 630-bed secondary care teaching hospital in Gyeonggi-do, South Korea.

When is the study starting and how long is it expected to run for?
January 2016 to December 2017

Who is funding the study?
Bundang Jesaeng Hospital

Who is the main contact?
Su Jin Jeong
Department of Internal Medicine, Yonsei University College of Medicine
50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
(Tel: +82-2-2228-1986; E-mail: JSJ@yuhs.ac.kr; Fax: +82-2-393-6884)


Trial website

Contact information

Type

Public

Primary contact

Dr Su Jin Jeong

ORCID ID

Contact details

Department of Internal Medicine
Yonsei University College of Medicine
50-1 Yonsei-ro
Seodaemun-gu
Seoul
03722
Korea
South
+82-2-2228-1986
JSJ@yuhs.ac.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Environmental disinfection with a photocatalyst antimicrobial coating as an adjunctive measure to control transmission of methicillin-resistant Staphylococcus aureus (MRSA) in patients in intensive care units (ICU): a prospective cohort study in a high-incidence setting

Acronym

Study hypothesis

We sought to evaluate the usefulness of a photocatalyst to reduce the risk of MRSA transmission, by comparing MRSA acquisition rate and nosocomial infection rate before and after photocatalyst coating.

Ethics approval

Institutional Review Board of Bundang Jesaeng Hospital Health System Clinical Trials Center, 02/06/2016, Jesaeng Hospital - infection 16-01.
Since the study had minimal health risk and the study subjects were anonymized, the Institutional Review Board waived the requirement for written informed consent from the patients.

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Methicillin-resistant Staphylococcus aureus (MRSA) infection

Intervention

A titanium dioxide-based photocatalyst was coated on high touch surfaces and walls. 5 months of pre-intervention data were compared with 5 months of post-intervention data. The incidence rates of multidrug-resistant organism acquisition and the rates of hospital-acquired blood stream infection, pneumonia, urinary tract infection, and Clostridium difficile–associated diseases were compared using Cox proportional hazards regression analysis.

Intervention type

Other

Phase

Drug names

Primary outcome measure

MRSA acquisition assessed using culture results which were obtained from patients’ nares up to 48 hours after ICU admission and on discharge from ICU.

Secondary outcome measures

1. Vancomycin-resistant Enterococcus spp. (VRE) acquisition assessed by reviewing culture results and medical records from admission until discharge from ICU
2. Multidrug-resistant Acinetobacter baumannii (MRAB) acquisition assessed by reviewing culture results and medical records from admission until discharge from ICU
3. Clostridium-difficile–associated disease (CDAD) acquisition assessed by reviewing culture results and medical records from admission until discharge from ICU
4. Hospital-acquired infections (HAI), including bloodstream infection, pneumonia, and urinary tract infection as defined by The Centers for Disease Control and Prevention, assessed by reviewing culture results and medical records from admission until discharge from ICU

Overall trial start date

01/01/2016

Overall trial end date

31/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Admitted to the medical intensive care unit during the study period.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

341 and 280 patients during baseline and intervention periods

Participant exclusion criteria

1. Aged <18 years
2. Hospitalized <72 hours

Recruitment start date

01/09/2016

Recruitment end date

31/07/2017

Locations

Countries of recruitment

Korea, South

Trial participating centre

Bundang Jaeseng hospital
180-2 Seohyeon-ro Bundang-gu Seongnam-si Gyeonggi-do
Seongnam
463-774
Korea, South

Sponsor information

Organisation

Bundang Jesaeng Hospital

Sponsor details

180-2 Seohyeon-ro
Bundang-gu
Seongnam-si
Gyeonggi-do
Seongnam
463-774
Korea
South
+82-31-779-0000
webmaster@dmc.or.kr

Sponsor type

Hospital/treatment centre

Website

http://www.dmc.or.kr/global/index.do?lang=en

Funders

Funder type

Hospital/treatment centre

Funder name

Bundang Jesaeng Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The research findings will be published in high impact research journals and presented at international conferences.

IPD sharing statement:
The datasets generated during and analysed during the current study will be available upon request from Su Jin Jeong (JSJ@yuhs.ac.kr) immediately after publication of the results. All of the anonymised individual participant data collected during the trial will be available, along with the study protocol and statistical analysis. These data will be available to any applicant for any purpose for an indefinite period.

Intention to publish date

30/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30509196

Publication citations

Additional files

Editorial Notes

05/12/2018: Publication reference added.