Efficacy of Ultraviolet Germicidal Irradiation Devices to Reduce Respiratory Infections in Nursing Homes: Cluster Randomized Crossover Trial (RESPROTECT)

Centre Hospitalier Emile Roux

Status: Enrolling

Conditions: Acute Respiratory Infections

Treatments: Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation)

Study type: Interventional

Funder types: Other

Identifiers

NCT06569160

RIPH2_GADEA_RESPROTECT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,200 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Center 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.

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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1,200 participants in 2 patient groups

UVGI Active during period 1, UVGI Sham during period 2

Other group

Treatment:

Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation)

UVGI Sham during period 1, UVGI Active during period 2

Other group

Treatment:

Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation)