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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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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.

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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Acute Respiratory Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cluster Randomized Crossover
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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UVGI Active during period 1, UVGI Sham during period 2

Group Type OTHER

Upper-room UVGI (Ultra-Violet Germicidal Irradiation)

Intervention Type DEVICE

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

Group Type OTHER

Upper-room UVGI (Ultra-Violet Germicidal Irradiation)

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.


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

ENH:

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ANRS | French National Research Agency on Emerging Infectious Diseases

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Emile Roux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

EHPAD du Centre hospitalier du Pays de Craponne sur Arzon

Craponne-sur-Arzon, , France

Site Status RECRUITING

EHPAD Paradis

Espaly-Saint-Marcel, , France

Site Status RECRUITING

EHPAD du Centre hospitalier Pierre Gallice

Langeac, , France

Site Status RECRUITING

EHPAD Les Terrasses de la Gazeille

Le Monastier-sur-Gazeille, , France

Site Status RECRUITING

EHPAD Les Patios du Velay

Le Puy-en-Velay, , France

Site Status RECRUITING

EHPAD Nazareth

Le Puy-en-Velay, , France

Site Status RECRUITING

EHPAD Saint-Joseph

Le Puy-en-Velay, , France

Site Status RECRUITING

EHPAD L'Age d'Or

Monistrol-sur-Loire, , France

Site Status RECRUITING

EHPAD Résidence Sigolène

Sainte-Sigolène, , France

Site Status RECRUITING

EHPAD Saint Jacques

Saugues, , France

Site Status RECRUITING

EHPAD Marie Goy

Vorey, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emilie GADEA, PhD

Role: CONTACT

+33 (0)4.71.04.31.27

Xavier ANGLARET, MD, PhD

Role: CONTACT

+33 (0)781877948

Facility Contacts

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Sophie LENGAGNE

Role: primary

+33 (0)471043526

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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RIPH2_GADEA_RESPROTECT

Identifier Type: -

Identifier Source: org_study_id

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