Impact du déploiement de Dispositifs d'Inactivation Des pathogènes de l'Air Par UVGI Dans la Lutte Contre Les Maladies Respiratoires Touchant Les résidents d'EHPAD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,687
- 试验地点
- 24
- 主要终点
- Incidence of severe acute symptomatic upper and lower respiratory infections
研究概览
简要总结
RESPROTECT is a trial aimed at evaluating the effectiveness of upper room ultraviolet devices in reducing the frequency of severe respiratory infections in elderly nursing homes. The study takes place in 12 nursing homes in the center of France. It started in October 2024, and its final results will be availble by mid-2026.
详细描述
The objective of this clinical trial is to determine whether ultraviolet germicidal irradiation (UVGI) can decrease the frequency of severe acute respiratory infections in elderly people living in nursing homes.
12 elderly nursing homes (ENH) will participate in the study. In all the ENHs included, UVGI devices will be installed in upper part under the ceiling of common rooms (refectories, group activity rooms, lounges) at the start of the study. The UVGI devices can be deactivated by installing an invisible internal filter. The inactivation filters will be installed by a technical team independent of the investigation team. Inactivation will therefore be carried out blind to the care givers and the investigation team.
The nursing homes included will be randomized into two arms:
- In arm A: the UVGI device will be left active during period 1, and filtered/deactivated during period 2.
- In arm B: the UVGI device will be filtered/deactivated during period 1 and left active during period 2.
The two periods will last 7 months each, and will take place two years in a row on the same dates (October 1 to April 30). They will be separated by a 5-month wash-out period (May 1 to September 30), during which all UVGI devices will be switched off in both arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Center Inclusion criteria:
- •Elderly Nursing homes (ENH):
- •Having a system for monitoring cases of upper and lower respiratory infections among their residents.
- •Agreeing to take part in the study
- •Undertaking to comply with the protocol
- •Accepting the installation of UVGI devices
- •Undertaking to provide all residents or their legal guardians/curators with an individual information leaflet.
排除标准
- •Not wishing to be equipped with UVGI devices in all rooms considered necessary to be equipped by the investigators
- •Having planned a major change to the structure (extension, renovation, closure, requalification, etc.) during the course of the study, which could affect the study population and/or UVGI air treatment devices.
- •Individual Inclusion criteria:
- •All residents present in one of the participating ENH at the start of each of the two study periods, or arriving in one of the participating ENH during one of the two periods, will be eligible
- •Individual Exclusion criteria :
- •Residents of the ENH included in the study who have expressed (personally or through a relative or legal representative) the wish that their personal data not be used for the study will not be included in the study.
研究组 & 干预措施
UVGI Active during period 1, UVGI Sham during period 2
干预措施: Upper-room UVGI (Ultra-Violet Germicidal Irradiation) (Device)
UVGI Sham during period 1, UVGI Active during period 2
干预措施: Upper-room UVGI (Ultra-Violet Germicidal Irradiation) (Device)
结局指标
主要结局
Incidence of severe acute symptomatic upper and lower respiratory infections
时间窗: From enrollment to the end of the second follow-up period (19 months later)
Acute symptomatic upper and lower respiratory infections include: sinusitis, otitis media, nasopharyngitis, angina, tracheitis, bronchitis, pneumonia, pulmonary abscesses and COPD exacerbations. Symptomatic infection with SARS-Cov-2 will be considered by default as a respiratory infection, even if extra-respiratory symptoms predominate. Severe acute respiratory infections = acute respiratory infections leading to oxygen therapy, hospitalization or death.
次要结局
- Incidence of all-cause hospitalisations or death(From enrollment to the end of the second follow-up period (19 months later))
- Viral and bacterial load in air samples(From enrollment to the end of the second follow-up period (19 months later))
- Viral and bacterial load on fomites samples(From enrollment to the end of the second follow-up period (19 months later))
- Incremental Cost-effectiveness ratio(From enrollment to the end of the second follow-up period (19 months later))
- Incidence of adverse events of interest, overall and by severity grade(From enrollment to the end of the second follow-up period (19 months later))
- Incidence of acute upper and lower respiratory infections, all grades of severity combined(From enrollment to the end of the second follow-up period (19 months later))
- Incidence of all-cause hospitalisations or death(From enrollment to the end of the second follow-up period (19 months later))
- Viral and bacterial load in air samples(From enrollment to the end of the second follow-up period (19 months later))
- Viral and bacterial load on fomites samples(From enrollment to the end of the second follow-up period (19 months later))
- Incremental Cost-effectiveness ratio(From enrollment to the end of the second follow-up period (19 months later))
- Incidence of adverse events of interest, overall and by severity grade(From enrollment to the end of the second follow-up period (19 months later))