Far-UVC and Infections in Long-term Care Facilities
A Protocol for a Controlled, Phase II, Multi-arm, Parallel-group, Superiority, Six-month Trial Comparing the Effectiveness of Far-UVC (222 nm) in Two Experimental Arms Against Standard Care in Preventing Viral and Bacterial Infections in Long-term Care Facilities
Background Elderly residents in long-term care (LTC) facilities are highly susceptible to infections, often leading to hospitalizations and placing significant strain on the healthcare sector. The COVID-19 pandemic underscored the importance of airborne pathogen transmission and highlighted the necessity for targeted interventions that require minimal healthcare personnel resources to protect elderly populations. Far-UVC light has emerged as a promising technology offering both germicidal efficacy and safety for human exposure, although its clinical impact remains sparsely studied. This study aims to evaluate the effectiveness of far-UVC (222 nm) in mitigating hospitalizations due to viral and bacterial infections among LTC residents.
Methods The study is designed as a controlled, phase II, multi-arm, parallel-group, superiority, 6-month trial conducted in LTC facilities in Denmark. The LTC facilities will receive either far-UVC lamps or standard care with an allocation ratio of 1:1:10. One of the LTC facilities will be equipped with far-UVC lamps (experimental arm one) in common areas, while another will be equipped with far-UVC lamps (experimental arm two) in common areas and residents' apartments. We plan to include 12 public LTC facilities in Vejle with 542 residents. Outcome data will be obtained from nationally validated health registers. The primary outcome is LTC facility-acquired infections (lower respiratory tract infections, urinary tract infections, and bloodstream infections), which cause hospitalization. The key secondary outcome is prescribed antibiotics at LTC facilities, alongside monitoring all-cause mortality, cause-specific mortality (infection), and adverse events.
Discussion This trial aims to determine the clinical impact of far-UVC technology in LTC facilities. In the case of sufficiently promising effectiveness, a large-scale cluster randomized phase III will be carried out.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Vejle, Denmark, 7100
- Research Unit of Clinical Microbiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Public LTC facilities in Vejle Municipality and the residents living in these facilities.
Exclusion Criteria:
LTC facilities: 1) non-standardized buildings (building type or layout); 2) facilities with an increased risk of infections, such as those sharing common areas with kindergartens; and 3) facilities for individuals with dementia.
Residents receiving respite care or living in assisted-living facilities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Standard care
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Standard Care (Treatment as Usual)
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Experimental: Far-UVC lamps in common areas
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The far-UVC lamp that will be used in this study is a UV222™ lamp (UV Medico A/S, Denmark), which contains a krypton chloride excimer light source emitting filtered far-UVC irradiance at 222 nm and 60° angle. The optical filter (Care 222®, Ushio Inc., Japan) attenuates residual wavelength emission outside the 222-nm peak. The output is 115 mW, with a far-UVC irradiance of 13.7 µW/cm2 one meter from the lamp. The lamps will be configured to operate automatically in duty cycles to ensure that the threshold limit value (TLV) of 23 mJ/cm2 for the residents and personnel, as recommended by the International Commission on Non-ionizing Radiation Protection, is not exceeded. The UV222™ lamp carries a CE mark, which certifies its compliance with all European Union health and safety standards. The lamps will be installed in the ceiling. The configuration of each lamp will depend on its location within the room, the size of the room, and the time of occupancy by the residents and personnel. |
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Experimental: Far-UVC lamps in common areas and residents' apartments
|
The far-UVC lamp that will be used in this study is a UV222™ lamp (UV Medico A/S, Denmark), which contains a krypton chloride excimer light source emitting filtered far-UVC irradiance at 222 nm and 60° angle. The optical filter (Care 222®, Ushio Inc., Japan) attenuates residual wavelength emission outside the 222-nm peak. The output is 115 mW, with a far-UVC irradiance of 13.7 µW/cm2 one meter from the lamp. The lamps will be configured to operate automatically in duty cycles to ensure that the threshold limit value (TLV) of 23 mJ/cm2 for the residents and personnel, as recommended by the International Commission on Non-ionizing Radiation Protection, is not exceeded. The UV222™ lamp carries a CE mark, which certifies its compliance with all European Union health and safety standards. The lamps will be installed in the ceiling. The configuration of each lamp will depend on its location within the room, the size of the room, and the time of occupancy by the residents and personnel. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of hospitalisations due to respiratory tract infections acquired at long-term care facility
Time Frame: 6 months
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6 months
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Number of hospitalisations due to urinary tract infections acquired at long-term care facility
Time Frame: 6 months
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6 months
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Number of hospitalisations due to bloodstream infections acquired at long-term care facility
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of systemic antimicrobial agents prescribed for respiratory (excluding antivirals) infections at the long-term care facility
Time Frame: 6 months
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6 months
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Number of systemic antimicrobial agents prescribed for urinary tract infections at the long-term care facility
Time Frame: 6 months
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6 months
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Number of systemic antimicrobial agents prescribed for skin infections at the long-term care facility
Time Frame: 6 months
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6 months
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Number of systemic antimicrobial agents prescribed for other infections at the long-term care facility
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Far-UVC and infections
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Study Protocol
Information comments: A protocol for a controlled, phase II, multi-arm, parallel-group, superiority, six-month trial comparing the effectiveness of far-UVC (222 nm) in two experimental arms against standard care in preventing viral and bacterial infections in long-term care facilities
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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