Clinical trial NCT06569160: Efficacy of Ultraviolet Germicidal Irradiation (UVGI) Devices to Decrease the Incidence of Respiratory Infections in Nursing Homes : a Cluster Randomized Crossover Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Infections
Keywords: Ultraviolet Germicidal Irradiation (UVGI); respiratory infections; nursing homes; elderly; cluster randomized crossover trial
Lead sponsor: Centre Hospitalier Emile Roux
Sponsor class: OTHER
Collaborators: name: ANRS | Maladies infectieuses émergentes
First posted: 2024-08-23
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster Randomized Crossover
Primary purpose: PREVENTION

Brief summary: OTECT is a trial aimed at evaluating the effectiveness of upper room ultraviolet devices in reducing the frequency and severity of 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.


Eligibility 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 Non-inclusion 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 eligibility criteria

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 Non-inclusion 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.

Primary outcomes:
measure: Incidence of acute symptomatic upper and lower respiratory infections, all severity grades combined
timeFrame: From enrollment to the end of the second follow-up period (19 months later)
Secondary outcomes:
measure: Incidence of severe acute respiratory infections
timeFrame: From enrollment to the end of the second follow-up period (19 months later)
measure: Incidence of all-cause hospitalisations or death
timeFrame: From enrollment to the end of the second follow-up period (19 months later)
measure: Viral and bacterial load in air samples
timeFrame: From enrollment to the end of the second follow-up period (19 months later)
measure: Viral and bacterial load on fomites samples
timeFrame: From enrollment to the end of the second follow-up period (19 months later)
measure: Incremental Cost-effectiveness ratio
timeFrame: From enrollment to the end of the second follow-up period (19 months later)
measure: Incidence of adverse events of interest, overall and by severity grade
timeFrame: From enrollment to the end of the second follow-up period (19 months later)
Other outcomes:
Locations:
city: Beaulieu
country: France
facility: EHPAD Notre Dame
city: Craponne sur Arzon
country: France
facility: EHPAD du Centre hospitalier du Pays de Craponne sur Arzon
city: Espaly Saint Marcel
country: France
facility: EHPAD Paradis
city: Langeac
country: France
facility: EHPAD du Centre hospitalier Pierre Gallice
city: Le Monastier sur Gazeille
country: France
facility: EHPAD Les Terrasses de la Gazeille
city: Le Puy en Velay
country: France
facility: EHPAD Nazareth
city: Le Puy en Velay
country: France
facility: EHPAD Saint-Joseph
city: Le Puy-en-Velay
country: France
facility: EHPAD Les Patios du Velay
city: Monistrol sur Loire
country: France
facility: EHPAD L'Age d'Or
city: Sainte Sigolène
country: France
facility: EHPAD Résidence Sigolène
city: Saugues
country: France
facility: EHPAD Saint Jacques
city: Vorey
country: France
facility: EHPAD Marie Goy
Study officials:
affiliation: Hôpital Emile Roux, le Puy en Velay
name: Cyril CORNILLE, MD
role: PRINCIPAL_INVESTIGATOR
References: