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Completed

NCT Number: NCT07511881

Far-UVC and 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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Unit of Clinical Microbiology

Vejle, 7100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Far-uvc (222 nm)

Radiation

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.

Standard Care (Treatment as Usual)

Other

Standard Care (Treatment as Usual)

Primary outcomes

  1. Number of hospitalisations due to respiratory tract infections acquired at long-term care facility

    Time frame: 6 months

  2. Number of hospitalisations due to urinary tract infections acquired at long-term care facility

    Time frame: 6 months

  3. Number of hospitalisations due to bloodstream infections acquired at long-term care facility

    Time frame: 6 months

Secondary outcomes

  1. Number of systemic antimicrobial agents prescribed for respiratory (excluding antivirals) infections at the long-term care facility

    Time frame: 6 months

  2. Number of systemic antimicrobial agents prescribed for urinary tract infections at the long-term care facility

    Time frame: 6 months

  3. Number of systemic antimicrobial agents prescribed for skin infections at the long-term care facility

    Time frame: 6 months

  4. Number of systemic antimicrobial agents prescribed for other infections at the long-term care facility

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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