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NCT Number: NCT06569160

Efficacy of Ultraviolet Germicidal Irradiation Devices to Reduce Respiratory Infections in Nursing Homes: Cluster Randomized Crossover Trial

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.

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Key information

Conditions

Acute Respiratory Infections Infections Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EHPAD Notre Dame, Beaulieu, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of severe acute symptomatic upper and lower respiratory infections

    Time frame: 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 outcomes

  1. Incidence of acute upper and lower respiratory infections, all grades of severity combined

    Time frame: 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.

  2. Incidence of all-cause hospitalisations or death

    Time frame: 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

  3. Viral and bacterial load in air samples

    Time frame: 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

  4. Viral and bacterial load on fomites samples

    Time frame: 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

  5. Incremental Cost-effectiveness ratio

    Time frame: From enrollment to the end of the second follow-up period (19 months later)

    Generated/avoided costs

  6. Incidence of adverse events of interest, overall and by severity grade

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Emile Roux

Other

Collaborators

  • ANRS, Emerging Infectious Diseases
  • University of Bordeaux

Registry information

Official study 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

Acronym: RESPROTECT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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