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
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
- 是
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
干预措施: Far-uvc (222 nm) (Radiation)
Far-UVC lamps in common areas and residents' apartments
干预措施: Far-uvc (222 nm) (Radiation)
Standard care
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)
