Efficacy of Ultraviolet Germicidal Irradiation (UVGI) Devices to Decrease the Incidence of Respiratory Infections in Nursing Homes : a Cluster Randomized Crossover Trial
- Conditions
- Acute Respiratory Infections
- Interventions
- Device: UVGI (Ultra-Violet Germicidal Irradiation Device)
- Registration Number
- NCT06569160
- Lead Sponsor
- Centre Hospitalier Emile Roux
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active then sham UVGI (Ultra-Violet Germicidal Irradiation Device) There are 2 follow-up periods in cross-over. The clusters will be with active UVGI devices during one period and with sham UV-filtered devices during the other. Sham then active UVGI (Ultra-Violet Germicidal Irradiation Device) There are 2 follow-up periods in cross-over. The clusters will be with active UVGI devices during one period and with sham UV-filtered devices during the other.
- Primary Outcome Measures
Name Time Method Incidence of acute symptomatic upper and lower respiratory infections, all severity grades combined 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
- Secondary Outcome Measures
Name Time Method Viral and bacterial load on fomites samples 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
Incremental Cost-effectiveness ratio From enrollment to the end of the second follow-up period (19 months later) Generated/avoided costs
Incidence of adverse events of interest, overall and by severity grade 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
Incidence of severe acute respiratory infections From enrollment to the end of the second follow-up period (19 months later) Severe acute respiratory infections are acute respiratory infections leading to oxygenotherapy, hospitalisation or death
Incidence of all-cause hospitalisations or death 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
Viral and bacterial load in air samples 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
Trial Locations
- Locations (12)
EHPAD Notre Dame
🇫🇷Beaulieu, France
EHPAD du Centre hospitalier du Pays de Craponne sur Arzon
🇫🇷Craponne sur Arzon, France
EHPAD Paradis
🇫🇷Espaly Saint Marcel, France
EHPAD du Centre hospitalier Pierre Gallice
🇫🇷Langeac, France
EHPAD Les Terrasses de la Gazeille
🇫🇷Le Monastier sur Gazeille, France
EHPAD Nazareth
🇫🇷Le Puy en Velay, France
EHPAD Saint-Joseph
🇫🇷Le Puy en Velay, France
EHPAD Les Patios du Velay
🇫🇷Le Puy-en-Velay, France
EHPAD L'Age d'Or
🇫🇷Monistrol sur Loire, France
EHPAD Résidence Sigolène
🇫🇷Sainte Sigolène, France
EHPAD Saint Jacques
🇫🇷Saugues, France
EHPAD Marie Goy
🇫🇷Vorey, France