Hospital Acquired InfectionsPhase 2/3NCT03795090

A Multi-level Antimicrobial Surface Coating for a Healthier Environment

A Phase 2/3 study testing Regular Patient privacy curtain and Antimicrobial Coated curtains in people with Hospital Acquired Infections, run by Hong Kong University of Science and Technology at 1 site in Hong Kong.

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

This project aimed to study the use of the multi-level antimicrobial coating in a working hospital environment. Patient privacy curtains from a public sector hospital were coated and installed in rehabilitation ward in comparison of normally washed curtains in the same setting and compared the mean reduction on both… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hospital Acquired Infections
What is being tested?: Regular Patient privacy curtain and Antimicrobial Coated curtains
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteHong Kong
Study dates: 1 Jun 2017to 30 Jun 2018
Phase: Phase 2/3
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 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A convalescence ward with reasonable amount of nursing activities
No recent history of outbreaks of communicable diseases in the wards

Who cannot join

Wards with little nursing activities including infirmary wards
Wards with frequent outbreaks which lead to excessive curtain changes

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Kowloon Hospital
Kowloon, 0000

Other trials in Hong Kong

About this study

Read the detailed description

A multi-level antimicrobial coating was produced in the Hong Kong University of Science and Technology (HKUST) laboratory using the newly developed staged flow micromixing to prepare contact-killing and anti-adhesion coating made of US-FDA approved polymeric materials. The process was optimized to scale-up the production to 5 liters per hour. 300 liters of the multi-level antimicrobial coating was prepared for the study for a total of 24 weeks as three liters of the coating was needed for one patient privacy curtain.
The study was conducted in the rehabilitation ward of the Kowloon Hospital including both male and female cubicles. It was carried out in three stages with each stage consisting of survey and a four weeks' observation period, separated by three weeks' washout period. In the rehabilitation ward of Kowloon Hospital, a set of male and female cubicle was recruited for the study after getting maximum number of bacterial contamination on patient privacy curtains in pilot study of 8 weeks. Each cubicle had 12 curtains besides admitted patients where all the samples are collected.
Environmental sampling was carried out using sponge swab on the surfaces of the patient privacy curtains. The total bacteria count and quantitative isolation of MRSA was done using established protocols. The total bacteria count provides a quantitative measure of surface cleanliness, while the methicillin-resistant Staphylococcus aureus (MRSA) count was indicative of the risk of contact transmission from contaminated surfaces. 2-4 weeks survey provided control data on the cleanliness of patients privacy curtains in terms of total bacteria and MRSA counts. During the study period, the Kowloon Hospital/Queen Elizabeth Hospital infection control team monitored MDROs regularly as part of their routine operation. The procedure and schedule was followed strictly the infection control protocol. All infection control measures implemented after isolation of MDROs were followed according to the hospital's usual practice as advised by the infection control team. In the study, the identification of the organisms in patients more than 48 hours after admission without prior isolation of the organisms in clinical or screening specimens was defined as nosocomial.
The investigators demonstrated a cross-over intervention study. In the first stage of study, half of the patient privacy curtains were considered as treatment (antimicrobial coated) and the other half of the curtains as control in the same setting in a cubicle. As the study was double blind, so coding was done to identify the treatment as control curtains.
Sample were taken from eight highly touched areas of 50x50 cm² on weekly bases for three consecutive weeks on 7th day of first installation. On each period/phase 480, 576 and 786 samples were collected accordingly using the developed sample protocol. In total, the investigators collected 1824 samples from 76 patient privacy curtains in which 912 (50%) were control curtain and 912 (50%) are antimicrobial coated curtains.
Healthcare workers from the participating wards were assessed for their acceptance of the multilevel antimicrobial disinfectant coating by way of a questionnaire. Additional reformulation may be necessary to increase the acceptability of the coating technology to the healthcare workers.
For the bacteria count, duplicate plates of tryptic soy agar (TSA) for total bacteria count and Chromagar MRSA (selective agar for MRSA detection) were used for enumeration. CFU/m² is calculated after 48 hours incubation at 37°C. Data was analyzed using Statistical Package for the Social Sciences (SPSS) V.25 to assess the effectiveness of the coating in reducing the contamination level of the surface. The total bacteria count on the patient privacy curtains was compared between the control and treatment group using Mann-Whitney test and T-test. ANOVA analysis allowed the comparison of different periods of study of phase wise as well as week wise. The significance of the statistical test is defined to have a P value <0.05.

Conditions: Hospital Acquired Infections
Being tested: Regular Patient privacy curtain, Antimicrobial Coated curtains
Keywords: Antimicrobial coating, MDRO, MRSA, Patient Privacy Curtains

What participants receive

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

Regular Patient privacy curtainCombination product
Laundered curtains, used in the hospital, coming from the hospital inventory.
Antimicrobial Coated curtainsCombination product
Antimicrobial coating consist of active polymers that are approved by USFDA and USEPA.

Study groups in NCT03795090
Study group	Role	What they receive
Regular Patient privacy curtain	Active comparator	Control arm is a regular patient privacy curtain, washed and dried in hospital laundry using commercially available sodium hypochlorite and hydrogen peroxide. Receives: Combination Product: Regular Patient privacy curtain
Antimicrobial Coated Curtains	Experimental	Treatment arm is an antimicrobial coated curtains, which is obtained by dipping the hospital laundered curtains into the antimicrobial coating. The curtains are then dried and provided to the nursing/supporting staff. Receives: Combination Product: Regular Patient privacy curtain; Combination Product: Antimicrobial Coated curtains

What is being measured

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

Change in total bacteria count and MRSA in control vs treatment patient privacy curtains
To quantify the effectiveness of antimicrobial coating, percentage change (both in log and linear scale) in mean bacterial count (CFU/m2 units) in control versus treatment curtains is used. The data was collected in 3 phases of 4 weeks each, so the time frame used is representative of the complete observation period.
Measured: 12 weeks
Durability of antimicrobial coating in affecting bacterial load amongst treated patient privacy curtains
Change in bacterial load amongst treatment curtains is observed as a function of time during each phase of the data collection period (for 4 weeks). In total, data was collected in 3 phases of 4 weeks each, so the total observation period is 12 weeks and timeframe of each frame is 4 weeks.
Measured: 12 weeks

Secondary outcomes (1)

Agreement/disagreement of hospital staff regarding technology acceptance and adaptation
A survey was conducted using a self-structured questionnaire to get feedback from the hospital staff regarding their acceptance of the technology. The questionnaire contained questions regarding the physical (smell, appearance and feel) aspects of the coating as well as general approval/disapproval based on their experience with the technology. A scale of -5(worst) to +5(best), with 0 representing neutral was used, representing a dimensionless quantity based on staff's personal preferences. Mean of the user's response to each question was used for quantification. The users observed the technology during the entire 12 weeks of the study period (during all 3 phases of data collection). Users were give a 4-week time period to submit their survey responses.
Measured: 4 weeks

Timeline

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

1 Jun 201730 Jun 2018

First posted7 Jan 2019
Study start1 Jun 2017
Primary completion30 Mar 2018
Study completion30 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Hospital Acquired InfectionsStudies of the same condition, open and under way.
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 2/3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Crossover
Model description: Phase 1, even numbers in coding are treatment and odd coded curtains are control (Blind) Phase 2, odd numbers in coding are treatment and even coded curtains are control (Blind) Phase 3, even numbers in coding are treatment and odd coded curtains are control (Blind)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03795090
Sponsor's protocol ID: ITT/008/15GP
Status last verified: Jan 2019
First submitted: 28 Nov 2018
Last updated: 7 Jan 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: This is under discussion and final decision will be made later.

Publications

Klein E, Smith DL, Laxminarayan R. Hospitalizations and deaths caused by methicillin-resistant Staphylococcus aureus, United States, 1999-2005. Emerg Infect Dis. 2007 Dec;13(12):1840-6. doi: 10.3201/eid1312.070629.
PubMed 18258033
de Kraker ME, Davey PG, Grundmann H; BURDEN study group. Mortality and hospital stay associated with resistant Staphylococcus aureus and Escherichia coli bacteremia: estimating the burden of antibiotic resistance in Europe. PLoS Med. 2011 Oct;8(10):e1001104. doi: 10.1371/journal.pmed.1001104. Epub 2011 Oct 11.
PubMed 22022233
Carling PC, Von Beheren S, Kim P, Woods C; Healthcare Environmental Hygiene Study Group. Intensive care unit environmental cleaning: an evaluation in sixteen hospitals using a novel assessment tool. J Hosp Infect. 2008 Jan;68(1):39-44. doi: 10.1016/j.jhin.2007.09.015. Epub 2007 Dec 11.
PubMed 18069083
Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51. doi: 10.1001/archinte.166.18.1945.
PubMed 17030826
Datta R, Platt R, Yokoe DS, Huang SS. Environmental cleaning intervention and risk of acquiring multidrug-resistant organisms from prior room occupants. Arch Intern Med. 2011 Mar 28;171(6):491-4. doi: 10.1001/archinternmed.2011.64.
PubMed 21444840
Otter JA, Yezli S, Perl TM, Barbut F, French GL. The role of 'no-touch' automated room disinfection systems in infection prevention and control. J Hosp Infect. 2013 Jan;83(1):1-13. doi: 10.1016/j.jhin.2012.10.002. Epub 2012 Nov 26.
PubMed 23195691
Carling PC, Parry MM, Rupp ME, Po JL, Dick B, Von Beheren S; Healthcare Environmental Hygiene Study Group. Improving cleaning of the environment surrounding patients in 36 acute care hospitals. Infect Control Hosp Epidemiol. 2008 Nov;29(11):1035-41. doi: 10.1086/591940.
PubMed 18851687

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?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-level Antimicrobial Surface Coating for a Healthier Environment
ClinicalTrials.gov ID: NCT03795090
Acronym / sponsor ID: ITT/008/15GP
Conditions: Hospital Acquired Infections
Keywords: Antimicrobial coating, MDRO, MRSA, Patient Privacy Curtains
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Hong Kong University of Science and TechnologyUniversity, hospital or other
Collaborators: Kowloon Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Innovation and Technology Commission, Hong Kong
Study start: 1 Jun 2017 (actual)
Primary completion: 30 Mar 2018 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 7 Jan 2019 (actual)
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

A multi-level antimicrobial coating was produced in the Hong Kong University of Science and Technology (HKUST) laboratory using the newly developed staged flow micromixing to prepare contact-killing and anti-adhesion coating made of US-FDA approved polymeric materials. The process was optimized to scale-up the production to 5 liters per hour. 300 liters of the multi-level antimicrobial coating was prepared for the study for a total of 24 weeks as three liters of the coating was needed for one patient privacy curtain.
The study was conducted in the rehabilitation ward of the Kowloon Hospital including both male and female cubicles. It was carried out in three stages with each stage consisting of survey and a four weeks' observation period, separated by three weeks' washout period. In the rehabilitation ward of Kowloon Hospital, a set of male and female cubicle was recruited for the study after getting maximum number of bacterial contamination on patient privacy curtains in pilot study of 8 weeks. Each cubicle had 12 curtains besides admitted patients where all the samples are collected.
Environmental sampling was carried out using sponge swab on the surfaces of the patient privacy curtains. The total bacteria count and quantitative isolation of MRSA was done using established protocols. The total bacteria count provides a quantitative measure of surface cleanliness, while the methicillin-resistant Staphylococcus aureus (MRSA) count was indicative of the risk of contact transmission from contaminated surfaces. 2-4 weeks survey provided control data on the cleanliness of patients privacy curtains in terms of total bacteria and MRSA counts. During the study period, the Kowloon Hospital/Queen Elizabeth Hospital infection control team monitored MDROs regularly as part of their routine operation. The procedure and schedule was followed strictly the infection control protocol. All infection control measures implemented after isolation of MDROs were followed according to the hospital's usual practice as advised by the infection control team. In the study, the identification of the organisms in patients more than 48 hours after admission without prior isolation of the organisms in clinical or screening specimens was defined as nosocomial.
The investigators demonstrated a cross-over intervention study. In the first stage of study, half of the patient privacy curtains were considered as treatment (antimicrobial coated) and the other half of the curtains as control in the same setting in a cubicle. As the study was double blind, so coding was done to identify the treatment as control curtains.
Sample were taken from eight highly touched areas of 50x50 cm² on weekly bases for three consecutive weeks on 7th day of first installation. On each period/phase 480, 576 and 786 samples were collected accordingly using the developed sample protocol. In total, the investigators collected 1824 samples from 76 patient privacy curtains in which 912 (50%) were control curtain and 912 (50%) are antimicrobial coated curtains.
Healthcare workers from the participating wards were assessed for their acceptance of the multilevel antimicrobial disinfectant coating by way of a questionnaire. Additional reformulation may be necessary to increase the acceptability of the coating technology to the healthcare workers.
For the bacteria count, duplicate plates of tryptic soy agar (TSA) for total bacteria count and Chromagar MRSA (selective agar for MRSA detection) were used for enumeration. CFU/m² is calculated after 48 hours incubation at 37°C. Data was analyzed using Statistical Package for the Social Sciences (SPSS) V.25 to assess the effectiveness of the coating in reducing the contamination level of the surface. The total bacteria count on the patient privacy curtains was compared between the control and treatment group using Mann-Whitney test and T-test. ANOVA analysis allowed the comparison of different periods of study of phase wise as well as week wise. The significance of the statistical test is defined to have a P value <0.05.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Phase 1, even numbers in coding are treatment and odd coded curtains are control (Blind) Phase 2, odd numbers in coding are treatment and even coded curtains are control (Blind) Phase 3, even numbers in coding are treatment and odd coded curtains are control (Blind)

Arm	Type	Receives
Regular Patient privacy curtain	Active comparator	Combination Product: Regular Patient privacy curtainControl arm is a regular patient privacy curtain, washed and dried in hospital laundry using commercially available sodium hypochlorite and hydrogen peroxide.
Antimicrobial Coated Curtains	Experimental	Combination Product: Regular Patient privacy curtain, Combination Product: Antimicrobial Coated curtainsTreatment arm is an antimicrobial coated curtains, which is obtained by dipping the hospital laundered curtains into the antimicrobial coating. The curtains are then dried and provided to the nursing/supporting staff.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

A convalescence ward with reasonable amount of nursing activities
No recent history of outbreaks of communicable diseases in the wards

Key exclusion criteria (2 listed)

Wards with little nursing activities including infirmary wards
Wards with frequent outbreaks which lead to excessive curtain changes

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
Regular Patient privacy curtainLaundered curtains, used in the hospital, coming from the hospital inventory.	Combination product	Antimicrobial Coated Curtains, Regular Patient privacy curtain
Antimicrobial Coated curtainsAntimicrobial coating consist of active polymers that are approved by USFDA and USEPA.	Combination product	Antimicrobial Coated Curtains

Primary outcome

Change in total bacteria count and MRSA in control vs treatment patient privacy curtains
Time frame: 12 weeks
To quantify the effectiveness of antimicrobial coating, percentage change (both in log and linear scale) in mean bacterial count (CFU/m2 units) in control versus treatment curtains is used. The data was collected in 3 phases of 4 weeks each, so the time frame used is representative of the complete observation period.
Durability of antimicrobial coating in affecting bacterial load amongst treated patient privacy curtains
Time frame: 12 weeks
Change in bacterial load amongst treatment curtains is observed as a function of time during each phase of the data collection period (for 4 weeks). In total, data was collected in 3 phases of 4 weeks each, so the total observation period is 12 weeks and timeframe of each frame is 4 weeks.

1 secondary outcome

Agreement/disagreement of hospital staff regarding technology acceptance and adaptation
Time frame: 4 weeks

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 7 Jan 2019.
Background: PubMed 18258033Klein E, Smith DL, Laxminarayan R. Hospitalizations and deaths caused by methicillin-resistant Staphylococcus aureus, United States, 1999-2005. Emerg Infect Dis. 2007 Dec;13(12):1840-6. doi: 10.3201/eid1312.070629.
Background: PubMed 22022233de Kraker ME, Davey PG, Grundmann H; BURDEN study group. Mortality and hospital stay associated with resistant Staphylococcus aureus and Escherichia coli bacteremia: estimating the burden of antibiotic resistance in Europe. PLoS Med. 2011 Oct;8(10):e1001104. doi: 10.1371/journal.pmed.1001104. Epub 2011 Oct 11.
Background: PubMed 18069083Carling PC, Von Beheren S, Kim P, Woods C; Healthcare Environmental Hygiene Study Group. Intensive care unit environmental cleaning: an evaluation in sixteen hospitals using a novel assessment tool. J Hosp Infect. 2008 Jan;68(1):39-44. doi: 10.1016/j.jhin.2007.09.015. Epub 2007 Dec 11.
Background: PubMed 17030826Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51. doi: 10.1001/archinte.166.18.1945.
Background: PubMed 21444840Datta R, Platt R, Yokoe DS, Huang SS. Environmental cleaning intervention and risk of acquiring multidrug-resistant organisms from prior room occupants. Arch Intern Med. 2011 Mar 28;171(6):491-4. doi: 10.1001/archinternmed.2011.64.
Background: PubMed 23195691Otter JA, Yezli S, Perl TM, Barbut F, French GL. The role of 'no-touch' automated room disinfection systems in infection prevention and control. J Hosp Infect. 2013 Jan;83(1):1-13. doi: 10.1016/j.jhin.2012.10.002. Epub 2012 Nov 26.
Background: PubMed 18851687Carling PC, Parry MM, Rupp ME, Po JL, Dick B, Von Beheren S; Healthcare Environmental Hygiene Study Group. Improving cleaning of the environment surrounding patients in 36 acute care hospitals. Infect Control Hosp Epidemiol. 2008 Nov;29(11):1035-41. doi: 10.1086/591940.
Individual participant dataSharing planned: Undecided. This is under discussion and final decision will be made later.

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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.

King Lun Yeung, PhD principal investigator

Hong Kong University of Science and Technology

Chritropher Lai, MBChB, FRCP study chair

Kowloon Hospital, Hong Kong

Dominic Tsang, MBChB, FRCP study director

Kowloon Hospital, Hong Kong

1 site 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 2 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 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in total bacteria count and MRSA in control vs treatment patient privacy curtains (time frame: 12 weeks). 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 NCT03795090, which also lists 7 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 7 Jan 2019.