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Trial registered on ANZCTR
Registration number
ACTRN12606000278538
Ethics application status
Approved
Date submitted
30/06/2006
Date registered
4/07/2006
Date last updated
5/11/2008
Type of registration
Retrospectively registered
Titles & IDs
Public title
Economic and Social Benefits of Treating and Preventing Influenza in Aged Care Facilities
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Scientific title
Economic and Social Benefits of Treating and Preventing Influenza in Aged Care Facilities
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Secondary ID [1]
273
0
University of Sydney: 03-2006/3/8446
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Universal Trial Number (UTN)
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Trial acronym
Nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza outbreak in an aged-care facility
1253
0
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Condition category
Condition code
Respiratory
1339
1339
0
0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This trial aims primarily to assess the value of two different policies for control of influenza outbreaks in aged-care facilities using the licensed antiviral drug oseltamivir (Tamiflu). The study will be carried out for three years (three influenza seasons). Early case detection and early use of treatment will apply to both trial arms. The main comparison will be between using oseltamivir for treating influenza-infected people only, compared with using oseltamivir for treating the sick and also offering it for influenza prophylaxis during an influenza outbreak.
The participating ACFs will be randomly allocated to either one of the two arms before the influenza season:
Arm 2: The treatment plus prophylaxis arm – oral Oseltamivir will be offered to staff and residents for treatment as above, and for prophylaxis of influenza to well staff and residents for 10 days (75mg daily) who have consented to participate and may have been exposed to the sick persons in the ACF where the influenza outbreak occurs.
Dosage interval will be doubled if the participant has severe renal impairment (creatinine clearance 10-30ml/min). Oseltamivir will not be used if the participant has end-stage renal failure or creatinine clearance is <10ml/min.
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Intervention code [1]
1185
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Treatment: Drugs
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Comparator / control treatment
Arm 1: The treatment only arm – oral Oseltamivir treatment for 5 days (75mg b.d.) will be offered to staff and residents who have consented to participate and are diagnosed with influenza within 48 hours from onset of symptoms.
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Control group
Active
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Outcomes
Primary outcome [1]
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Attack rate of influenza in staff/residents of an aged-care facility in an outbreak
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Assessment method [1]
1825
0
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Timepoint [1]
1825
0
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Secondary outcome [1]
3192
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Death within 4 weeks from onset of influenza symptoms of patient & case fatality rate within 4 weeks from onset of the outbreak
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Assessment method [1]
3192
0
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Timepoint [1]
3192
0
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Secondary outcome [2]
3193
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Pneumonia incidence within 4 weeks from onset of influenza symptoms of patient
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Assessment method [2]
3193
0
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Timepoint [2]
3193
0
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Secondary outcome [3]
3194
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Hospital admission incidence within 4 weeks from onset of influenza symptoms of patient
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Assessment method [3]
3194
0
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Timepoint [3]
3194
0
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Secondary outcome [4]
3195
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Staff absenteeism during the outbreak
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Assessment method [4]
3195
0
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Timepoint [4]
3195
0
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Secondary outcome [5]
3196
0
Development of oseltamivir resistant influenza during the course of treatment or prophylaxis
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Assessment method [5]
3196
0
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Timepoint [5]
3196
0
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Secondary outcome [6]
3197
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Adverse events following oseltamivir within 4 weeks from commencing course
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Assessment method [6]
3197
0
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Timepoint [6]
3197
0
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Secondary outcome [7]
3198
0
Duration of each outbreak/time to cessation of outbreak
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Assessment method [7]
3198
0
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Timepoint [7]
3198
0
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Secondary outcome [8]
3199
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Quality of life of participants (assessed by EQ-5D) before and 4–6 weeks after onset of the outbreak
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Assessment method [8]
3199
0
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Timepoint [8]
3199
0
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Eligibility
Key inclusion criteria
Adult residents residing in a participating aged-care facility during an influenza outbreakStaff member in a participating aged-care facility during an influenza outbreak Volunteers and unpaid carers in a participating aged-care facility during an influenza outbreak who regularly spend substantial time being in contact with residents.
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Minimum age
18
Years
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
People who have a contraindication to oseltamivirStaff members and volunteers/ carers who are pregnantPatients undergoing dialysis for end stage renal disease or whose creatinine clearance is estimated to be 10ml/min or lessPeople who have symptoms of influenza for more than 48 hours will be ineligible to receive treatment with oseltamivir.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed through randomised allocation by an independent statistician on recruitment of participating aged-care facilities
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation was used. A participating aged-care facility was the unit of randomisation. The size of each block was variable. The random order was generated by a secure computer program. The allocation was stratified by the type of basic physical layout of the facility.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/06/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
3200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
1464
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Government body
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Name [1]
1464
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Australian Research Council Linkage Grant
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Address [1]
1464
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GPO Box 2702
CANBERRA
ACT 2601
AUSTRALIA
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Country [1]
1464
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
The University of Sydney
Camperdown New South Wales 2006
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
1293
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The Children’s Hospital at Westmead
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Address [1]
1293
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Locked Bag 4001, Westmead, NSW 2145
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Country [1]
1293
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
2844
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University of Sydney
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Ethics committee address [1]
2844
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Ethics committee country [1]
2844
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Australia
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Date submitted for ethics approval [1]
2844
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Approval date [1]
2844
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21/03/2006
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Ethics approval number [1]
2844
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03-2006/3/8446
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Ethics committee name [2]
2845
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The Children’s Hospital at Westmead
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Ethics committee address [2]
2845
0
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Ethics committee country [2]
2845
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Australia
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Date submitted for ethics approval [2]
2845
0
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Approval date [2]
2845
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29/06/2006
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Ethics approval number [2]
2845
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2006/057
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Summary
Brief summary
Influenza (the ‘flu’) may cause mild to severe illness, and some people, including older people, are at a higher risk for death and serious complications. Flu is easier to catch where people live in communities like aged-care facilities (ACFs). This trial aims primarily to assess the value of two different policies for control of influenza outbreaks (when several people get infected at the same time) in ACFs using the antiviral drug oseltamivir (Tamiflu). It is licensed for treating and preventing flu. This research will help to find out the benefits of starting the drug treatment early for people who have flu, compared with starting the drug treatment early for people who have flu, and also giving the drug to well people in the aged care facility who have been exposed to the sick people. The study will be carried out for three years (three influenza seasons) commencing in 2006.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
35156
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Address
35156
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Country
35156
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Phone
35156
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Fax
35156
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Email
35156
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Contact person for public queries
Name
10374
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Cameron Moffatt
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Address
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National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
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Country
10374
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Australia
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Phone
10374
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+61 2 98450121
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Fax
10374
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+61 2 98451418
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Email
10374
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cameronM@chw,edu.au
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Contact person for scientific queries
Name
1302
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Professor Robert Booy
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Address
1302
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National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
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Country
1302
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Australia
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Phone
1302
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+61 2 98451415
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Fax
1302
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+61 2 98451418
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Email
1302
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RobertB2@chw.edu.au
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
Neuraminidase inhibitors for preventing and treating influenza in adults and children.
2014
https://dx.doi.org/10.1002/14651858.CD008965.pub4
N.B. These documents automatically identified may not have been verified by the study sponsor.
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