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

May 29, 2026 updated by: Centre Hospitalier Emile Roux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1687

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Beaulieu, France, 43021
        • EHPAD Notre Dame
      • Craponne-sur-Arzon, France, 43500
        • EHPAD du Centre hospitalier du Pays de Craponne sur Arzon
      • Espaly-Saint-Marcel, France, 43000
        • EHPAD Paradis
      • Langeac, France, 43300
        • EHPAD du Centre hospitalier Pierre Gallice
      • Le Monastier-sur-Gazeille, France, 43150
        • EHPAD Les Terrasses de la Gazeille
      • Le Puy-en-Velay, France, 43000
        • EHPAD Nazareth
      • Le Puy-en-Velay, France, 43000
        • EHPAD Saint-Joseph
      • Le Puy-en-Velay, France, 43000
        • EHPAD Les Patios du Velay
      • Monistrol-sur-Loire, France, 43120
        • EHPAD L'Age d'Or
      • Sainte-Sigolène, France, 43600
        • EHPAD Résidence Sigolène
      • Saugues, France, 43170
        • EHPAD Saint Jacques
      • Vorey, France, 43800
        • EHPAD Marie Goy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: UVGI Active during period 1, UVGI Sham during period 2
Device: 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.
Other: UVGI Sham during period 1, UVGI Active during period 2
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of severe acute symptomatic upper and lower respiratory infections
Time Frame: 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.
From enrollment to the end of the second follow-up period (19 months later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all-cause hospitalisations or death
Time Frame: From enrollment to the end of the second follow-up period (19 months later)
All-cause hospitalisations or death include hospitalisation due to acute respiratory infections, hospitalisations due to any other documented or undocumented cause, death to acute respiratory infections, and deaths from any other documented or undocumented cause
From enrollment to the end of the second follow-up period (19 months later)
Viral and bacterial load in air samples
Time Frame: From enrollment to the end of the second follow-up period (19 months later)
Air samples collected every 7 weeks in 2 common living areas per center
From enrollment to the end of the second follow-up period (19 months later)
Viral and bacterial load on fomites samples
Time Frame: From enrollment to the end of the second follow-up period (19 months later)
Samples collected every 7 weeks in 2 common living areas per center
From enrollment to the end of the second follow-up period (19 months later)
Incremental Cost-effectiveness ratio
Time Frame: From enrollment to the end of the second follow-up period (19 months later)
Generated/avoided costs
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
Time Frame: From enrollment to the end of the second follow-up period (19 months later)
Adverse events of interest: keratitis and erythematous skin eruptions in body areas exposed to light
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
Time Frame: 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.
From enrollment to the end of the second follow-up period (19 months later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Emile Roux

Collaborators

University of Bordeaux
ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Cyril CORNILLE, MD, Hôpital Emile Roux, le Puy en Velay

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

April 30, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPH2_GADEA_RESPROTECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD collected throughout the trial

IPD Sharing Time Frame

Study protocol, SAP and ICF: start date 1st July 2025. No end date. CSR: start date 1st July 2026. No end date.

IPD: 1st October 2026. No end date.

IPD Sharing Access Criteria

Study protocol, SAP and ICF: free access on clinicaltrials.gov IPD: on demand to trial team. Approval by the Scientific Advisory Board.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Infections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe