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Acute Respiratory InfectionsRESPROTECTNCT06569160

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

A study testing Upper-room UVGI (Ultra-Violet Germicidal Irradiation) in people with Acute Respiratory Infections, run by Centre Hospitalier Emile Roux at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Acute Respiratory Infections
What is being tested?
Upper-room UVGI (Ultra-Violet Germicidal Irradiation)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,687 participants
Where
12 sitesFrance
Study dates
1 Oct 2024to 30 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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 locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites
  • EHPAD Notre Dame

    Beaulieu, 43021

  • EHPAD du Centre hospitalier du Pays de Craponne sur Arzon

    Craponne-sur-Arzon, 43500

  • EHPAD Paradis

    Espaly-Saint-Marcel, 43000

  • EHPAD du Centre hospitalier Pierre Gallice

    Langeac, 43300

  • EHPAD Les Terrasses de la Gazeille

    Le Monastier-sur-Gazeille, 43150

  • EHPAD Les Patios du Velay

    Le Puy-en-Velay, 43000

  • EHPAD Nazareth

    Le Puy-en-Velay, 43000

  • EHPAD Saint-Joseph

    Le Puy-en-Velay, 43000

  • EHPAD L'Age d'Or

    Monistrol-sur-Loire, 43120

  • EHPAD Résidence Sigolène

    Sainte-Sigolène, 43600

  • EHPAD Saint Jacques

    Saugues, 43170

  • EHPAD Marie Goy

    Vorey, 43800

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Upper-room UVGI (Ultra-Violet Germicidal Irradiation)
Keywords
Ultraviolet Germicidal Irradiation (UVGI); respiratory infections; nursing homes; elderly; cluster randomized crossover trial
Medical subject headings
Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upper-room UVGI (Ultra-Violet Germicidal Irradiation)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.

Study groups in NCT06569160
Study groupRoleWhat they receive
UVGI Active during period 1, UVGI Sham during period 2OtherNot described
Receives: Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation)
UVGI Sham during period 1, UVGI Active during period 2OtherNot described
Receives: Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of severe acute symptomatic upper and lower respiratory infections

    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.

    Measured: From enrollment to the end of the second follow-up period (19 months later)

Secondary outcomes (6)
  1. Incidence of acute upper and lower respiratory infections, all grades of severity combined

    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.

    Measured: From enrollment to the end of the second follow-up period (19 months later)

  2. Incidence of all-cause hospitalisations or death

    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

    Measured: From enrollment to the end of the second follow-up period (19 months later)

  3. Viral and bacterial load in air samples

    Air samples collected every 7 weeks in 2 common living areas per center

    Measured: From enrollment to the end of the second follow-up period (19 months later)

  4. Viral and bacterial load on fomites samples

    Samples collected every 7 weeks in 2 common living areas per center

    Measured: From enrollment to the end of the second follow-up period (19 months later)

  5. Incremental Cost-effectiveness ratio

    Generated/avoided costs

    Measured: From enrollment to the end of the second follow-up period (19 months later)

  6. Incidence of adverse events of interest, overall and by severity grade

    Adverse events of interest: keratitis and erythematous skin eruptions in body areas exposed to light

    Measured: From enrollment to the end of the second follow-up period (19 months later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2024
  2. Study start1 Oct 2024
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Cluster Randomized Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,687 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06569160
Sponsor's protocol ID
RIPH2_GADEA_RESPROTECT
Other IDs
ID-RCB
Acronym
RESPROTECT
Status last verified
Jul 2026
First submitted
25 Jul 2024
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD collected throughout the trial

Publications

  • Cornille C, Luneau E, Gabillard D, Mathieu M, Lengagne S, Perrin E, Ezzouak M, Gondol F, Peuriere M, Maubert B, Saint-Sardos P, Peghaire S, Blanc FX, Ekouevi DK, Anglaret X, Gadea E. Efficacy of ultraviolet germicidal irradiation (UVGI) devices to decrease the incidence of respiratory infections in nursing homes: study protocol for a cluster randomized crossover trial (RESPROTECT). Trials. 2026 May 20;27(1):493. doi: 10.1186/s13063-026-09797-y.

    PubMed 42163326

Questions about this trial

What is this clinical trial studying?

A study testing Upper-room UVGI (Ultra-Violet Germicidal Irradiation) in people with Acute Respiratory Infections, run by Centre Hospitalier Emile Roux at 12 sites in France.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06569160, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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