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: * 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,200
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.
EHPAD Notre Dame
Beaulieu, France
RECRUITINGEHPAD du Centre hospitalier du Pays de Craponne sur Arzon
Craponne-sur-Arzon, France
RECRUITINGIncidence 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.
Time frame: From enrollment to the end of the second follow-up period (19 months later)
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.
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of the second follow-up period (19 months later)
Viral and bacterial load on fomites samples
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
EHPAD Paradis
Espaly-Saint-Marcel, France
RECRUITINGEHPAD du Centre hospitalier Pierre Gallice
Langeac, France
RECRUITINGEHPAD Les Terrasses de la Gazeille
Le Monastier-sur-Gazeille, France
RECRUITINGEHPAD Les Patios du Velay
Le Puy-en-Velay, France
RECRUITINGEHPAD Nazareth
Le Puy-en-Velay, France
RECRUITINGEHPAD Saint-Joseph
Le Puy-en-Velay, France
RECRUITINGEHPAD L'Age d'Or
Monistrol-sur-Loire, France
RECRUITINGEHPAD Résidence Sigolène
Sainte-Sigolène, France
RECRUITING...and 2 more locations
Samples collected every 7 weeks in 2 common living areas per center
Time frame: From enrollment to the end of the second follow-up period (19 months later)
Incremental Cost-effectiveness ratio
Generated/avoided costs
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
Adverse events of interest: keratitis and erythematous skin eruptions in body areas exposed to light
Time frame: From enrollment to the end of the second follow-up period (19 months later)