Bacterial ContaminationNCT04927806
The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms
A study testing Silver Knight in people with Bacterial Contamination, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The aim of this study is to investigates the effectiveness of antimicrobial breathing system on multidrug-resistant organisms (MDRO). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Contamination
- What is being tested?
- Silver Knight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2021to 30 Jun 2022
- 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
- mechanical ventilators in Medisive CareUnit (MICU)
Who cannot join
- Using ventilators for less than seven days
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
The aim of this study is to investigates the effectiveness of antimicrobial breathing system on multidrug-resistant organisms (MDRO).
Read the detailed description
Background:
Cross transmission via skin contact and environmental media is the main route for common outbreak of health care-associated infection which more likely to be improved or prevented by infection control program. Silver Knight uses silver ions to disrupt the normal enzymatic activities of bacteria for reducing microbial growth within, and on, the surface of the breathing systems. It functions as a safe, quick and effective catalyst to deactivate pathogenic bacteria and prevent their proliferation. However, there was no study comparing the standard ventilator circuit with Silver Knight. This study focuses on the effectiveness of antimicrobial breathing system in MDRO which including carbapenem-resistant, vancomycin-resistant and multi-drug resistant.
Study Design:
This is a prospective, randomized study in a single hospital in the intensive care unit.
Methods:
In this study, we conduct a cluster-randomized crossover, single-centre trial. There are two groups:
- Control group: standard ventilator circuit in odd number month.
- Experimental group: Silver Knight in even number month This study is expected to recruit 200 subjects. During this period, the ventilator circuits are all routinely used, only the tubing will not be discarded after use for specimen collection.And the MDRO on the surfaces of ventilator circuits will be analyzed and evaluated.
Effect:
We expect the antimicrobial breathing system could be more effectively than the standard ventilator circuit. The policy related to current ventilator circuit will be revised according to the results of this study.
Key words:
Antimicrobial Breathing system, ventilator circuits, multidrug-resistant organisms (MDRO)
- Conditions
- Bacterial Contamination
- Being tested
- Silver Knight
- Keywords
- Bacterial contamination, nosocomail infection, bacterial detection rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver KnightDevice
Silver Knight breathing systems are all validated for up to seven days use, and remain active, in unopened packaging, for up to five years. Silver Knight is proven to help reduce the incidence of MRSA infection and other organisms including:
- Staphyloccus epidermis
- Pseudomonas aeruginosa
- Klebsiella pneumoniae
- Acinetobacter calcoaceticus
- Escherichia coli
| Study group | Role | What they receive |
|---|---|---|
| SilverKnight group | Experimental | Silver Knight is an anti-microbial additive that uses silver ions to disrupt the normal enzymatic activities of bacteria Receives: Device: Silver Knight |
| Control group | No intervention | The control group uses standard ventilator circuits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial contamination
comparison of the two ventilator systems
Measured: one month
Secondary outcomes (1)
bacterial detection rate
comparison of the two ventilator systems
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Nov 2021
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacterial ContaminationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this study, we conduct a cluster-randomized crossover, multicenter trial.There are two groups: 1. Control group: standard ventilator circuit in odd number month. 2. Experimental group: Silver Knight in even number month
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Wen-Lun Liu, MD, Principal investigator, Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927806
- Sponsor's protocol ID
- PL-202108037M
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zilahi G, Artigas A, Martin-Loeches I. What's new in multidrug-resistant pathogens in the ICU? Ann Intensive Care. 2016 Dec;6(1):96. doi: 10.1186/s13613-016-0199-4. Epub 2016 Oct 6.
PubMed 27714706Chao KY, Liu WL, Chen CY, Su CH, Yang SH, Huang YT. Bacterial Colonization of Silver-Additive Ventilator Circuit in Patients Receiving Mechanical Ventilation: A Randomized Controlled Trial. Clin Respir J. 2025 Mar;19(3):e70058. doi: 10.1111/crj.70058.
PubMed 40052538
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms
- ClinicalTrials.gov ID
- NCT04927806
- Acronym / sponsor ID
- PL-202108037M
- Conditions
- Bacterial Contamination
- Keywords
- Bacterial contamination, nosocomail infection, bacterial detection rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Jun 2021 (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.
The aim of this study is to investigates the effectiveness of antimicrobial breathing system on multidrug-resistant organisms (MDRO).
Detailed description
Background:
Cross transmission via skin contact and environmental media is the main route for common outbreak of health care-associated infection which more likely to be improved or prevented by infection control program. Silver Knight uses silver ions to disrupt the normal enzymatic activities of bacteria for reducing microbial growth within, and on, the surface of the breathing systems. It functions as a safe, quick and effective catalyst to deactivate pathogenic bacteria and prevent their proliferation. However, there was no study comparing the standard ventilator circuit with Silver Knight. This study focuses on the effectiveness of antimicrobial breathing system in MDRO which including carbapenem-resistant, vancomycin-resistant and multi-drug resistant.
Study Design:
This is a prospective, randomized study in a single hospital in the intensive care unit.
Methods:
In this study, we conduct a cluster-randomized crossover, single-centre trial. There are two groups:
- Control group: standard ventilator circuit in odd number month.
- Experimental group: Silver Knight in even number month This study is expected to recruit 200 subjects. During this period, the ventilator circuits are all routinely used, only the tubing will not be discarded after use for specimen collection.And the MDRO on the surfaces of ventilator circuits will be analyzed and evaluated.
Effect:
We expect the antimicrobial breathing system could be more effectively than the standard ventilator circuit. The policy related to current ventilator circuit will be revised according to the results of this study.
Key words:
Antimicrobial Breathing system, ventilator circuits, multidrug-resistant organisms (MDRO)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, we conduct a cluster-randomized crossover, multicenter trial.There are two groups: 1. Control group: standard ventilator circuit in odd number month. 2. Experimental group: Silver Knight in even number month
| Arm | Type | Receives |
|---|---|---|
| SilverKnight group | Experimental | Device: Silver KnightSilver Knight is an anti-microbial additive that uses silver ions to disrupt the normal enzymatic activities of bacteria |
| Control group | No intervention | –The control group uses standard ventilator circuits. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- mechanical ventilators in Medisive CareUnit (MICU)
Key exclusion criteria (1 listed)
- Using ventilators for less than seven days
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 |
|---|---|---|
| Silver KnightSilver Knight breathing systems are all validated for up to seven days use, and remain active, in unopened packaging, for up to five years. Silver Knight is proven to help reduce the incidence of MRSA infection and other organisms including: * Staphyloccus epidermis * Pseudomonas aeruginosa * Klebsiella pneumoniae * Acinetobacter calcoaceticus * Escherichia coli | Device | SilverKnight group |
Primary outcome
bacterial contamination
Time frame: one month
comparison of the two ventilator systems
1 secondary outcome
bacterial detection rate
Time frame: one month
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 1 Mar 2023.
- Background: PubMed 27714706Zilahi G, Artigas A, Martin-Loeches I. What's new in multidrug-resistant pathogens in the ICU? Ann Intensive Care. 2016 Dec;6(1):96. doi: 10.1186/s13613-016-0199-4. Epub 2016 Oct 6.
- Derived from this study: PubMed 40052538Chao KY, Liu WL, Chen CY, Su CH, Yang SH, Huang YT. Bacterial Colonization of Silver-Additive Ventilator Circuit in Patients Receiving Mechanical Ventilation: A Randomized Controlled Trial. Clin Respir J. 2025 Mar;19(3):e70058. doi: 10.1111/crj.70058.
- Individual participant dataSharing planned: No
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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.
Wen-Lun Liu, MD principal investigator
Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Knight in people with Bacterial Contamination, run by Fu Jen Catholic University at 1 site in Taiwan.
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 1 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 1 Mar 2023. 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 Taiwan. 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?
bacterial contamination (time frame: one month). 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 NCT04927806, which also lists 2 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 1 Mar 2023.