Acute Respiratory Infections
Conditions
Keywords
Ultraviolet Germicidal Irradiation (UVGI); respiratory infections; nursing homes; elderly; cluster randomized crossover trial
Brief 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. 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.
Interventions
DEVICEUpper-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.
Sponsors
Centre Hospitalier Emile Roux
ANRS, Emerging Infectious Diseases
University of Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Cluster Randomized Crossover
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe acute symptomatic upper and lower respiratory infections | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute upper and lower respiratory infections, all grades of severity 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. |
| 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 |
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCyril CORNILLE, MD
Hôpital Emile Roux, le Puy en Velay
Outcome results
None listed