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| Name | Class |
|---|---|
| ANRS, Emerging Infectious Diseases | OTHER_GOV |
| University of Bordeaux | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UVGI Active during period 1, UVGI Sham during period 2 | Other |
| |
| UVGI Sham during period 1, UVGI Active during period 2 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of the second follow-up period (19 months later) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Center Inclusion criteria:
Elderly Nursing homes (ENH):
Center Exclusion criteria:
ENH:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Cyril CORNILLE, MD | Hôpital Emile Roux, le Puy en Velay | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EHPAD Notre Dame | Beaulieu | 43021 | France | |||
| EHPAD du Centre hospitalier du Pays de Craponne sur Arzon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42163326 | Derived | 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. doi: 10.1186/s13063-026-09797-y. Online ahead of print. |
| Label | URL |
|---|---|
| Protocol publication (Trials 2026, in press) | View source |
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All IPD collected throughout the trial
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.
Study protocol, SAP and ICF: free access on clinicaltrials.gov IPD: on demand to trial team. Approval by the Scientific Advisory Board.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2025 | Oct 22, 2025 |
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Cluster Randomized Crossover
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| 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 | 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 | 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 | From enrollment to the end of the second follow-up period (19 months later) |
| Incremental Cost-effectiveness ratio | 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 | 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) |
| Craponne-sur-Arzon |
| 43500 |
| France |
| EHPAD Paradis | Espaly-Saint-Marcel | 43000 | France |
| EHPAD du Centre hospitalier Pierre Gallice | Langeac | 43300 | France |
| EHPAD Les Terrasses de la Gazeille | Le Monastier-sur-Gazeille | 43150 | France |
| EHPAD Les Patios du Velay | Le Puy-en-Velay | 43000 | France |
| EHPAD Nazareth | Le Puy-en-Velay | 43000 | France |
| EHPAD Saint-Joseph | Le Puy-en-Velay | 43000 | France |
| EHPAD L'Age d'Or | Monistrol-sur-Loire | 43120 | France |
| EHPAD Résidence Sigolène | Sainte-Sigolène | 43600 | France |
| EHPAD Saint Jacques | Saugues | 43170 | France |
| EHPAD Marie Goy | Vorey | 43800 | France |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2026 | May 29, 2026 | SAP_004.pdf |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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