Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000567820
Ethics application status
Approved
Date submitted
4/05/2021
Date registered
14/05/2021
Date last updated
21/01/2024
Date data sharing statement initially provided
14/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a parallel crossover randomised controlled trial
Scientific title
Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a parallel crossover randomised controlled trial
Secondary ID [1] 303214 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PETRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 320361 0
Aged care 320362 0
Condition category
Condition code
Respiratory 318267 318267 0 0
Other respiratory disorders / diseases
Public Health 319631 319631 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our aim is to evaluate the respiratory viral epidemiology in residential aged care facility (RACF) environments and determine the potential of readily translatable measures to address airborne components of transmission within these settings.

The study is a 4-period parallel cross-over randomised controlled trial targeting air-sterilisation strategies to reduce the burden of airborne viral infections in residential aged care settings. The intervention will use commercially available upper-room germicidal ultraviolet (GUV). Commercially available upper-room GUV (with effective air-mixing) has been shown to reduce airborne tuberculosis transmission at a rate equivalent to adding significant room air changes per hour, and its high efficacy against airborne viruses (including influenza and SARS-CoV-1) has been demonstrated. Moreover, when GUV has been deployed in "in-duct" or standalone systems, it has been shown to result in significant reductions in both viral viability and rates of symptomatic respiratory infections. These GUV modalities might therefore be combined to achieve effective air disinfection in accordance with aged care facility layout, occupancy, and air-ventilation systems.

Each residential aged care facility will have the option to receive all forms of GUV intervention, with final layouts and suitability to retrospectively install determined by facility and GUV engineers. The intervention approach may use a combination of:
1. in-duct GUV placed prior to air return vents in systems serving shared spaces (such as dining areas);
2. ceiling/wall-mounted GUV units situated in a pattern that provides air sterilisation of connecting corridors and spaces between resident rooms, with additional units providing coverage to high traffic spaces (such as lift areas); and
3. standalone fan-driven GUV units used in occasional areas (such as cinema units, chapels, and workshop rooms).

In situ appliance performance will be tested according to ASHRAE Standard 185.1, and deployed in such a way as to achieve an equivalent level of coverage between comparator sites.

Each facility contains zones assigned to both the intervention and the control condition twice (once for each condition in each of two consecutive respiratory infection seasons). The intervention will include a treatment and a control arm:
• Arm 1 (treatment): The GUV intervention will be applied for a 6-week period, followed by a 2-week washout period (to account for respiratory virus incubation periods), and then a crossover to the control period for 6-weeks, followed by a final 2-week washout.
• Arm 2 (control): The control period will be applied for 6-weeks, followed by a 2-week washout period, and then a crossover to the GUV intervention will apply for 6-weeks, followed by a final 2-week washout.

For each arm, the residential aged care facility engineers will be responsible for operating and modifying the GUV devices. The engineers will not be involved in the data capture or analysis process. To account for differences in facility characteristics, assessment will be based on within-facility comparisons of discrete zones, using the crossover design. Paired zones will be highly similar in size, layout, and occupancy, allowing randomisation for the control/intervention order within the study design. Similar GUV strategies will be employed in paired areas within each facility to account for temporal variation in seasonal virus levels.
Intervention code [1] 319527 0
Prevention
Intervention code [2] 319528 0
Treatment: Devices
Comparator / control treatment
Arm 2 (control):
All sites will be installed with GUV devices as previously described. For the most precise comparisons, each zone will be directly compared against itself following control and treatment periods. For the control period, the GUV units will be switched off. The control period will be applied for 6-weeks, followed by a 2-week washout period, and then a crossover to the GUV intervention for 6-weeks, followed by a final 2-week washout.

Control group
Active

Outcomes
Primary outcome [1] 326264 0
Rates of symptomatic respiratory infection in residents of aged care facilities.

The study will utilise the existing framework for surveillance of influenza-like illness in residential aged care facilities, the guidelines of which have been published by both national (communicable diseases network Australia) and local authorities (communicable diseases control branch of South Australia). They define influenza-like illness clinically as the sudden onset of symptoms and at least one of three respiratory symptoms: cough (new or worsening); sore throat; shortness of breath; and at least one of four systemic symptoms: fever or feverishness; malaise; headache; myalgia. If a resident meets this definition, discussions with the treating GP will occur for influenza testing influenza by nucleic acid amplification using a nose and/or throat swab. To ensure thorough and consistent case identification according to study definitions, dedicated research nurses will be assigned to each facility (including paired zones) for the duration of the study schedule, liaising directly with facility staff and residents. Research nurses will complete the symptomatic respiratory infection data capture sheet, which will serve as the data collection instrument for the trial. This data will be used to confirm that the clinical case definition of a symptomatic respiratory infection has been met. Multiple episodes of infection in the same resident will be counted as case occasions for the same resident provided that the following criteria are met: at least 2 weeks have passed since the initial case definition was met; the symptoms triggering the subsequent case definition have developed acutely (within 72 hours of recording); however if the same pathogen is detected for both episodes, these will be considered one episode of infection, not two. Participating facilities will request medical officers send specimens to SA Pathology where specimens sent for influenza testing are also routinely tested for a range of other respiratory pathogens including COVID-19. Patients will have met the primary outcome based on fulfilling the symptomatic respiratory infection clinical definition, even if no swab was performed or if the swab result is negative. However, de-identified data on swab results will be obtained from SA Pathology. Residents who meet the clinical definition and also have a positive test will have met the definition of a confirmed symptomatic respiratory viral infection.
Timepoint [1] 326264 0
Rates of symptomatic respiratory infection will be continuously recorded throughout the day, daily, for the entirety of the 16-week study.
Secondary outcome [1] 390813 0
Rates of hospitalisation for complications associated with a respiratory infection.

Hospital admissions, or presentations at hospital emergency departments for complications associated with acute respiratory infection, will be identified through facility records. Viral diagnostic data will be generated by SA Pathology and accessed via the Millennium Laboratory Information System. International Classification of Diseases (ICD) coding (Australian modification; ICD-10-AM), performed at hospital discharge, will be used to identify features of infection that would not be captured by viral swab results.
Timepoint [1] 390813 0
Rates of hospitalisation for complications associated with respiratory infection will be continuously recorded throughout the day, daily, for the entirety of the 16-week study.
Secondary outcome [2] 390818 0
Respiratory virus detection and quantification in facility air samples through determination of levels of airborne and surface viral particles within residential aged care facilities.

Air sample collection utilising a Bertin Coriolis micro liquid output air sampler will detect aerosol-borne respiratory syncytial viral and bacterial agents causing respiratory symptoms. Composite levels of particles in the air will be determined using quantitative, non-multiplexed versions of PCR assays.
Timepoint [2] 390818 0
Respiratory viral and bacterial detection and quantification in facility air samples will be recorded weekly throughout the entirety of the 16-week study.
Secondary outcome [3] 390819 0
Rates of respiratory viral and bacterial detection and quantification in facility fomite samples.

Samples will be collected from non-absorbent fomites with pre-wetted (0.25 strength Ringer's solution) polyester-tipped swabs using a fixed area template. Composite levels of viral particles in air and fomite samples will be determined using quantitative, non-multiplexed versions of PCR assays.
Timepoint [3] 390819 0
Rates of respiratory viral and bacterial detection and quantification in facility fomite samples will be recorded weekly throughout the entirety of the 16-week study.

Eligibility
Key inclusion criteria
Residential aged care facilities within South Australia with the ability to sub-divide resident populations into discrete areas that enable concurrent comparison of interventions in facility cohorts which are otherwise subject to the same facility practices (e.g. environmental cleaning, staffing, and social distancing).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residential aged care facilities within South Australia that do not have the ability to sub-divide resident populations into discrete areas that enable concurrent comparison of interventions in facility cohorts that are otherwise subject to the same facility practices (e.g. environmental cleaning, staffing, and social distancing).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a cluster randomised 4-period cross-over design in which each residential aged care facility contains zones assigned to both the intervention and the control condition twice (once for each condition in each of 2 consecutive respiratory infection seasons), we calculate that a sample size of n=10 zones (across five facilities, from three aged care providers), with an average size of n=40 residents per zone, will provide 95% power to detect an absolute 5% difference in symptomatic infections i.e. a 5% infection rate versus a 10% infection rate. This calculation assumes an intra-class correlation (ICC) within facilities of p=0.03 as well as a within-zone ICC of p=0.20, a total of 4 measurement periods per zone (2 for each season) and a variance inflation factor of VIF=(1-p)/4=0.2 for the relative number of zones required in total compared with a parallel group design. Site dropouts are highly unlikely as centres have committed to the study and contingencies for facility disruption have been identified. However, additional facilities have been made available, should they be required.

Difference in infection rates between the two periods will be assessed using mixed effects logistic regression with fixed effects for the treatment group, treatment order, intervention period and a period-to-treatment interaction term in order to assess for a possible treatment-to-period interaction effect. The zone and facility will be included as random intercepts with zones nested within facilities. As a sensitivity analysis, we will also assess differences in infection rates using wider time-windows for each period in order to account for the incubation period of infection. Analysis will be performed using Stata version 16. A two-sided type-1 error rate of alpha=0.05 will be used to indicate statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/07/2021
Actual
16/08/2021
Date of last participant enrolment
Anticipated
17/09/2021
Actual
20/09/2021
Date of last data collection
Anticipated
30/09/2023
Actual
15/11/2023
Sample size
Target
400
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18475 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 32785 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 307617 0
Government body
Name [1] 307617 0
Medical Research Future Fund, the Department of Health, The Commonwealth of Australia.
Country [1] 307617 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute
Address
SAHMRI, North Terrace, Adelaide SA 5000 Australia
PO Box 11060, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 308334 0
University
Name [1] 308334 0
Flinders University
Address [1] 308334 0
Sturt Rd, Bedford Park SA 5042
Country [1] 308334 0
Australia
Other collaborator category [1] 281604 0
Individual
Name [1] 281604 0
Professor Maria Crotty
Address [1] 281604 0
Flinders Medical Centre
Sturt Rd
Bedford Park
SA 5042
Country [1] 281604 0
Australia
Other collaborator category [2] 281605 0
Individual
Name [2] 281605 0
Professor Lidia Morawska
Address [2] 281605 0
Queensland University of Technology
2 George St, Brisbane City QLD 4000
Country [2] 281605 0
Australia
Other collaborator category [3] 281606 0
Individual
Name [3] 281606 0
Professor Scott Bell
Address [3] 281606 0
University of Queensland
Child Health Research Centre
Level 6, Centre for Children's Health Research (CCHR)
62 Graham Street
South Brisbane QLD 4101, Australia
Country [3] 281606 0
Australia
Other collaborator category [4] 281607 0
Individual
Name [4] 281607 0
Dr Ming Qiao
Address [4] 281607 0
SA Pathology
Frome Rd, Adelaide SA 5000
PO Box 14 Rundle Mall, SA 5000
Country [4] 281607 0
Australia
Other collaborator category [5] 281608 0
Individual
Name [5] 281608 0
Professor Richard Woodman
Address [5] 281608 0
Flinders Medical Centre
Sturt Rd
Bedford Park
SA 5042
Country [5] 281608 0
Australia
Other collaborator category [6] 281609 0
Individual
Name [6] 281609 0
Associate Professor Craig Whitehead
Address [6] 281609 0
Flinders Medical Centre
Sturt Rd
Bedford Park
SA 5042
Country [6] 281609 0
Australia
Other collaborator category [7] 281610 0
Commercial sector/Industry
Name [7] 281610 0
Helping Hand
Address [7] 281610 0
209 The Golden Way
Golden Grove SA 5125
Australia
Country [7] 281610 0
Australia
Other collaborator category [8] 281611 0
Commercial sector/Industry
Name [8] 281611 0
Laftech
Address [8] 281611 0
12 Royan Place
Bayswater North, Victoria 3153
Country [8] 281611 0
Australia
Other collaborator category [9] 281757 0
Individual
Name [9] 281757 0
Dr Lito Papanicolas
Address [9] 281757 0
Flinders Medical Centre
Sturt Rd
Bedford Park
SA 5042
Country [9] 281757 0
Australia
Other collaborator category [10] 281758 0
Individual
Name [10] 281758 0
A/Prof Maria Inacio
Address [10] 281758 0
SAHMRI
North Tce, Adelaide SA 5000
Country [10] 281758 0
Australia
Other collaborator category [11] 281759 0
Individual
Name [11] 281759 0
A/Prof Caroline Miller
Address [11] 281759 0
SAHMRI
North Tce, Adelaide SA 5000
Country [11] 281759 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307976 0
Bellberry Ltd
Ethics committee address [1] 307976 0
Ethics committee country [1] 307976 0
Australia
Date submitted for ethics approval [1] 307976 0
19/05/2021
Approval date [1] 307976 0
15/07/2021
Ethics approval number [1] 307976 0
2021-04-403

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108070 0
Prof Geraint Rogers
Address 108070 0
SAHMRI, North Terrace, Adelaide SA 5000 Australia
PO Box 11060, Adelaide SA 5001
Country 108070 0
Australia
Phone 108070 0
+61 08 8204 7614
Fax 108070 0
Email 108070 0
[email protected]
Contact person for public queries
Name 108071 0
Geraint Rogers
Address 108071 0
SAHMRI, North Terrace, Adelaide SA 5000 Australia
PO Box 11060, Adelaide SA 5001
Country 108071 0
Australia
Phone 108071 0
+61 08 8204 7614
Fax 108071 0
Email 108071 0
[email protected]
Contact person for scientific queries
Name 108072 0
Geraint Rogers
Address 108072 0
SAHMRI, North Terrace, Adelaide SA 5000 Australia
PO Box 11060, Adelaide SA 5001
Country 108072 0
Australia
Phone 108072 0
+61 08 8204 7614
Fax 108072 0
Email 108072 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant/facility data underlying published results, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
For purposes linked to the aims in the approved proposal, and for meta-analyses.
How or where can data be obtained?
Access subject to approvals by the Principal Investigator ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePrevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a two-arm crossover randomised controlled trial protocol.2021https://dx.doi.org/10.1186/s12879-021-06659-7
EmbaseRandomized trials on non-pharmaceutical interventions for COVID-19: a scoping review.2022https://dx.doi.org/10.1136/bmjebm-2021-111825
N.B. These documents automatically identified may not have been verified by the study sponsor.