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

NCT06569160 | Recruiting DMC

• 1 other identifier: RIPH2_GADEA_RESPROTECT
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 12

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.

Conditions

Acute Respiratory Infections

Keywords

Ultraviolet Germicidal Irradiation (UVGI); respiratory infections; nursing homes; elderly; cluster randomized crossover trial

Outcome Measures

Primary Outcomes (1)

• Incidence 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.

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

Secondary Outcomes (6)

• 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)

• Incidence of all-cause hospitalisations or death

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

• Viral and bacterial load in air samples

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

• Viral and bacterial load on fomites samples

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

• Incremental Cost-effectiveness ratio

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

Study Arms (2)

UVGI Active during period 1, UVGI Sham during period 2

OTHER

Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation)

UVGI Sham during period 1, UVGI Active during period 2

OTHER

Device: Upper-room UVGI (Ultra-Violet Germicidal Irradiation)

Interventions

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.

UVGI Active during period 1, UVGI Sham during period 2; UVGI Sham during period 1, UVGI Active during period 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• Centre Hospitalier Emile Roux: lead
• ANRS | French National Research Agency on Emerging Infectious Diseases: collaborator

Study Sites (12)

EHPAD Notre Dame

Beaulieu, 43021, France

RECRUITING

EHPAD du Centre hospitalier du Pays de Craponne sur Arzon

Craponne-sur-Arzon, 43500, France

RECRUITING

EHPAD Paradis

Espaly-Saint-Marcel, 43000, France

RECRUITING

EHPAD du Centre hospitalier Pierre Gallice

Langeac, 43300, France

RECRUITING

EHPAD Les Terrasses de la Gazeille

Le Monastier-sur-Gazeille, 43150, France

RECRUITING

EHPAD Les Patios du Velay

Le Puy-en-Velay, 43000, France

RECRUITING

EHPAD Nazareth

Le Puy-en-Velay, 43000, France

RECRUITING

EHPAD Saint-Joseph

Le Puy-en-Velay, 43000, France

RECRUITING

EHPAD L'Age d'Or

Monistrol-sur-Loire, 43120, France

RECRUITING

EHPAD Résidence Sigolène

Sainte-Sigolène, 43600, France

RECRUITING

EHPAD Saint Jacques

Saugues, 43170, France

RECRUITING

EHPAD Marie Goy

Vorey, 43800, France

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Cyril CORNILLE, MD

  Hôpital Emile Roux, le Puy en Velay

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie GADEA, PhD

CONTACT

+33 (0)4.71.04.31.27; emilie.gadea@ch-lepuy.fr

Xavier ANGLARET, MD, PhD

CONTACT

+33 (0)781877948; xavier.anglaret@u-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Crossover

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 23, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Study protocol, SAP and ICF: start date 1st July 2025. No end date. CSR: start date 1st July 2026. No end date. IPD: 1st October 2026. No end date.
• Access Criteria: Study protocol, SAP and ICF: free access on clinicaltrials.gov IPD: on demand to trial team. Approval by the Scientific Advisory Board.

Locations

FR (12)