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.
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
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.
- Conditions
- Acute Respiratory Infections
- 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 group | Role | What they receive |
|---|---|---|
| UVGI Active during period 1, UVGI Sham during period 2 | Other | Not described Receives: Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation) |
| UVGI Sham during period 1, UVGI Active during period 2 | Other | Not 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.
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)
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)
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)
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)
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)
Incremental Cost-effectiveness ratio
Generated/avoided costs
Measured: 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
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.
- First posted23 Aug 2024
- Study start1 Oct 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Cyril CORNILLE, MD, Principal investigator, Hôpital Emile Roux, le Puy en Velay
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06569160
- Acronym / sponsor ID
- RESPROTECT / RIPH2_GADEA_RESPROTECT
- Conditions
- Acute Respiratory Infections
- Keywords
- Ultraviolet Germicidal Irradiation (UVGI); respiratory infections; nursing homes; elderly; cluster randomized crossover trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,687 participants (actual)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, University of Bordeaux
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Crossover
| Arm | Type | Receives |
|---|---|---|
| UVGI Active during period 1, UVGI Sham during period 2 | Other | Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation) |
| UVGI Sham during period 1, UVGI Active during period 2 | Other | Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | UVGI Active during period 1, UVGI Sham during period 2, UVGI Sham during period 1, UVGI Active during period 2 |
Primary outcome
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.
6 secondary outcomes
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)
Incidence of all-cause hospitalisations or death
Time frame: 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)
Viral and bacterial load on fomites samples
Time frame: 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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 42163326Cornille 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.
- Protocol publication (Trials 2026, in press)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyril CORNILLE, MD principal investigator
Hôpital Emile Roux, le Puy en Velay
12 sites in 1 country: see every site and its status.
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.