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Trial registered on ANZCTR


Registration number
ACTRN12615000638538
Ethics application status
Not yet submitted
Date submitted
19/05/2015
Date registered
19/06/2015
Date last updated
19/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Role of Oseltamivir During Influenza Outbreaks in Aged-care Facilities in the Context of Optimal Influenza Vaccination and Infection Control
Scientific title
Do Residential Aged Care Facilities benefit from oseltamivir treatment of cases plus prophylaxis of contacts, versus oseltamivir treatment of cases alone, with respect to reducing influenza outbreak frequency, duration and complications?
Secondary ID [1] 286750 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza in Residential Aged Care Facilities 295108 0
Surveillance systems for influenza in Residential Aged Care Facilities 295109 0
Condition category
Condition code
Infection 295358 295358 0 0
Other infectious diseases
Public Health 295359 295359 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oseltamivir treatment course in influenza cases in staff or residents plus oseltamivir prophylaxis of contacts
Treatment regimen of oseltamivir: 75mg orally twice a day with a meal/snack for five days in those diagnosed within 48 hours of influenza symptoms by rapid bedside or laboratory testing

Prophylaxis regimen: 75mg orally daily of oseltamivir for ten days or until outbreak is declared over, whichever is longer, with snack/meal


Medicines will be charted on a medication chart and signed off as administered by staff within the aged care facility which documents compliance


Electronic surveillance systems implemented in aged care facilities for early identification of an influenza outbreak: defined as 3 or more epidemiologically linked cases of influenza-like illness in residents or staff of the facility within a period of 72 hours PLUS at least one case having a positive laboratory test OR at least two having a positive point of care test“.

The Australian Aged Care Standards and Accreditation agency require ACFs to incorporate infection surveillance within their infection control programmes. There are currently no systematic surveillance systems for infectious diseases across ACFs in Australia, although most have some internal surveillance is carried out. Improved surveillance of can enable earlier outbreak identification and control. This study will implement electronic surveillance systems and observe their uptake, benefits and drawbacks.

Rapid point-of-care tests (POCT) for influenza are used once to diagnose those with influenza-like symptoms - Nose and throat swabs will be collected from each consenting resident and staff member during screening by ACF staff using flocked swabs for rapid point of care testing (SOFIA / QUICKVUE (Registered Trademark) Influenza A+B Test; Quidel Corp., San Diego, CA., USA or BinaxNOW (Registered Trademark) Influenza A&B; Alere Inc., Florida, USA).
Where feasible, a second nasal swab from a sample of patients affected by the outbreak will be collected for nucleic acid testing for influenza virus DNA, both POCT positive and POCT negative but symptomatic; study staff may assist with this. These will be transported to the laboratory at 4 degrees C in viral transport medium
Intervention code [1] 291900 0
Treatment: Drugs
Comparator / control treatment
oseltamivir treatment course in influenza cases in staff or residents with no oseltamivir prophylaxis of contacts

Treatment regimen of oseltamivir: 75mg orally twice a day with a meal/snack for five days in those diagnosed within 48 hours of influenza symptoms by rapid bedside or laboratory testing
Control group
Active

Outcomes
Primary outcome [1] 295101 0
Attack rate of Influenza in Treatment and Prophylaxis vs. Treatment only Aged Care Facilities; each positive case will be diagnosed by rapid point-of-care bedside testing, and a subset of these will have laboratory PCR confirmation
Timepoint [1] 295101 0
At the end of the influenza season: usually 8-12 weeks
Secondary outcome [1] 314777 0

Hospital admission incidence within four weeks (4/52) from onset of influenza symptoms as notified to study staff by aged-care facility staff on follow up
Timepoint [1] 314777 0
At the end of the influenza season: usually 8-12 weeks
Secondary outcome [2] 315023 0
Case fatality rate within 4/52 from onset of an outbreak: information obtained by active case follow up by study staff
Timepoint [2] 315023 0
At the end of the influenza season: usually 8-12 weeks
Secondary outcome [3] 315024 0
Pneumonia in subjects within 4/52 from outset of influenza symptoms; as diagnosed by general practitioners overseeing patient care and documented in patient file or, if admitted to hospital, by checking the discharge summary for notification of pneumonia
Timepoint [3] 315024 0
At the end of the influenza season: usually 8-12 weeks
Secondary outcome [4] 315025 0
Adverse events in subjects within four weeks of commencing oseltamivir
Timepoint [4] 315025 0
Adverse events of oseltamivir are defined a sign or symptom temporally associated with the use of oseltamivir not present at baseline or which resolved for one or more days and which reappeared during oseltamivir treatment or prophylaxis. Determined by active case follow up
Secondary outcome [5] 315026 0
Outbreak duration: date of the onset of the first symptomatic resident in a confirmed influenza outbreak to date of onset of last case.
Timepoint [5] 315026 0
At the end of the influenza season: usually 8-12 weeks

Eligibility
Key inclusion criteria
Any participating residential aged care facility (ACF) from whom written consent has been obtained is eligible to receive the randomly assigned intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Subjects who have a known hypersensitivity to oseltamivir or any of its components (see Appendix)
*ACFs who withhold consent
*Residents or staff who have had symptoms suggestive of influenza for longer than 72 hours, as from then there is no *Staff who are pregnant or currently breastfeeding.

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)
Active phone surveillance of ACFs for any residents or staff with predefined influenza-like illness will be conducted; when an influenza outbreak is identified the intervention will be triggered in the ACF
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A third-party researcher assigned participating ACFs (within each stratum) to one of the oseltamivir use strategies by using a computerized stratified random process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
cluster randomised trial with ACFs being the unit of randomisation
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 37 ACF per treatment arm would give 90% power at a two-sided alpha of 0.05 to detect a reduction in attack rate from 10% to 3%, assuming an average of 45 residents per ACF and intra-cluster correlation coefficient (ICC) of 0.1.

In comparisons of baseline characteristics of ACF consented residents and staff, we will use (1) Two-sample t-test for continuous data with normal distribution, (2) Wilcoxon's Rank Sum Test for continuous variables with non-normal distribution, and (3) Two-sample Chi-square Test for binomial data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291293 0
Government body
Name [1] 291293 0
National Health and Medical Research Council
Country [1] 291293 0
Australia
Primary sponsor type
Hospital
Name
Children's Hospital, Westmead: National Centre for Immunisation Research and Surveillance
Address
contact person: Professor Robert Booy
National Centre for Immunisation Research and Surveillance
Kids Research Institute at The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 290059 0
Government body
Name [1] 290059 0
New South Wales Ministry of Health
Address [1] 290059 0
contact person: Dr. Vicky Sheppeard
NSW MOH
73 Miller Street
North Sydney NSW 2060
Australia

Postal address:
Locked Mail Bag 961
North Sydney NSW 2059
Australia
Country [1] 290059 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292861 0
Ethics Committees of The University of Sydney and The Children's Hospital at Westmead.
Ethics committee address [1] 292861 0
Ethics committee country [1] 292861 0
Australia
Date submitted for ethics approval [1] 292861 0
06/07/2015
Approval date [1] 292861 0
Ethics approval number [1] 292861 0

Summary
Brief summary
This protocol proposes a cluster-randomised study of 70-100 aged-care facilities with partnership between various stakeholders: aged care facilities, clinical researchers, general practitioners, government public health bodies, and relevant industry partners. It has two main purposes: (i) to examine the impact of oseltamivir, as treatment only, versus treatment and prophylaxis, for residents and staff of ACFs during influenza outbreaks with respect to morbidity, mortality and outbreak size, and (ii) to develop and test an enhanced surveillance system, utilising bedside rapid point-of-care tests with laboratory confirmation, for respiratory infection outbreaks in ACFs; both in the context of promoting influenza vaccine uptake and infection control measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57390 0
Prof Robert Booy
Address 57390 0
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St, Westmead
Post: Locked Bag 4001, Westmead NSW 2145, Australia
Country 57390 0
Australia
Phone 57390 0
+61 2 9845 0000
Fax 57390 0
Email 57390 0
[email protected]
Contact person for public queries
Name 57391 0
Robert Booy
Address 57391 0
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St, Westmead
Post: Locked Bag 4001, Westmead NSW 2145, Australia
Country 57391 0
Australia
Phone 57391 0
+61 2 9845 0000
Fax 57391 0
Email 57391 0
[email protected]
Contact person for scientific queries
Name 57392 0
Robert Booy
Address 57392 0
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St, Westmead
Post: Locked Bag 4001, Westmead NSW 2145, Australia
Country 57392 0
Australia
Phone 57392 0
+61 2 9845 0000
Fax 57392 0
Email 57392 0
[email protected]

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Results publications and other study-related documents

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