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临床试验/NCT07511881
NCT07511881已完成不适用

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

Vejle Hospital1 个研究点 分布在 1 个国家目标入组 635 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
635
试验地点
1
主要终点
Number of hospitalisations due to respiratory tract infections acquired at long-term care facility

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Public LTC facilities in Vejle Municipality and the residents living in these facilities.

排除标准

  • 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.

研究组 & 干预措施

Far-UVC lamps in common areas

Experimental

干预措施: Far-uvc (222 nm) (Radiation)

Far-UVC lamps in common areas and residents' apartments

Experimental

干预措施: Far-uvc (222 nm) (Radiation)

Standard care

Other

干预措施: Standard Care (Treatment as Usual) (Other)

结局指标

主要结局

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

时间窗: 6 months

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

时间窗: 6 months

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

时间窗: 6 months

次要结局

  • Number of systemic antimicrobial agents prescribed for other infections at the long-term care facility(6 months)
  • Number of systemic antimicrobial agents prescribed for respiratory (excluding antivirals) infections at the long-term care facility(6 months)
  • Number of systemic antimicrobial agents prescribed for urinary tract infections at the long-term care facility(6 months)
  • Number of systemic antimicrobial agents prescribed for skin infections at the long-term care facility(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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