COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621000567820.aspx

Prof Geraint Rogers

geraint.rogers@sahmri.com

2021-05-14

Recruiting

RCT

Randomized

Crossover

Open label

single-center

Prevention

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).

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).

2

South Australian Health and Medical Research Institute

18

100

Australia

High risk patients

N/A

400

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. [Rates of symptomatic respiratory infection will be continuously recorded throughout the day; daily; for the entirety of the 16-week study.]

Not reported

[{"arm_notes": "", "treatment_id": 1341, "treatment_name": "Upper-room germicidal ultraviolet (guv)", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]