Efficacy of Ultraviolet Germicidal Irradiation Devices to Reduce Respiratory Infections in Nursing Homes: Cluster Randomized Crossover Trial
NCT ID: NCT06569160
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1200 participants
INTERVENTIONAL
2024-10-01
2026-06-01
Brief Summary
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Detailed Description
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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.
The main questions the study aims to answer is: do active UVGI devices decrease the number of acute respiratory infections leading to oxygen therapy, hospitalization or death during the study periods.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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UVGI Active during period 1, UVGI Sham during period 2
Upper-room UVGI (Ultra-Violet Germicidal Irradiation)
Nursing homes are equipped with UVGI devices in all common living places. 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 centers 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 equipments will be switched off in both arms.
UVGI Sham during period 1, UVGI Active during period 2
Upper-room UVGI (Ultra-Violet Germicidal Irradiation)
Nursing homes are equipped with UVGI devices in all common living places. 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 centers 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 equipments will be switched off in both arms.
Interventions
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Upper-room UVGI (Ultra-Violet Germicidal Irradiation)
Nursing homes are equipped with UVGI devices in all common living places. 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 centers 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 equipments will be switched off in both arms.
Eligibility Criteria
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Inclusion Criteria
* 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.
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
Exclusion Criteria
* 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.
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.
ALL
Yes
Sponsors
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ANRS | French National Research Agency on Emerging Infectious Diseases
UNKNOWN
Centre Hospitalier Emile Roux
OTHER
Responsible Party
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Principal Investigators
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Cyril CORNILLE, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Emile Roux, le Puy en Velay
Locations
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EHPAD Notre Dame
Beaulieu, , France
EHPAD du Centre hospitalier du Pays de Craponne sur Arzon
Craponne-sur-Arzon, , France
EHPAD Paradis
Espaly-Saint-Marcel, , France
EHPAD du Centre hospitalier Pierre Gallice
Langeac, , France
EHPAD Les Terrasses de la Gazeille
Le Monastier-sur-Gazeille, , France
EHPAD Les Patios du Velay
Le Puy-en-Velay, , France
EHPAD Nazareth
Le Puy-en-Velay, , France
EHPAD Saint-Joseph
Le Puy-en-Velay, , France
EHPAD L'Age d'Or
Monistrol-sur-Loire, , France
EHPAD Résidence Sigolène
Sainte-Sigolène, , France
EHPAD Saint Jacques
Saugues, , France
EHPAD Marie Goy
Vorey, , France
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RIPH2_GADEA_RESPROTECT
Identifier Type: -
Identifier Source: org_study_id
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