Trial Review

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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
Scientific title
Economic and Social Benefits of Treating and Preventing Influenza in Aged Care Facilities
Secondary ID [1] 273 0
University of Sydney: 03-2006/3/8446
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza outbreak in an aged-care facility 1253 0
Condition category
Condition code
Respiratory 1339 1339 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1185 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 1825 0
Attack rate of influenza in staff/residents of an aged-care facility in an outbreak
Timepoint [1] 1825 0
Secondary outcome [1] 3192 0
Death within 4 weeks from onset of influenza symptoms of patient & case fatality rate within 4 weeks from onset of the outbreak
Timepoint [1] 3192 0
Secondary outcome [2] 3193 0
Pneumonia incidence within 4 weeks from onset of influenza symptoms of patient
Timepoint [2] 3193 0
Secondary outcome [3] 3194 0
Hospital admission incidence within 4 weeks from onset of influenza symptoms of patient
Timepoint [3] 3194 0
Secondary outcome [4] 3195 0
Staff absenteeism during the outbreak
Timepoint [4] 3195 0
Secondary outcome [5] 3196 0
Development of oseltamivir resistant influenza during the course of treatment or prophylaxis
Timepoint [5] 3196 0
Secondary outcome [6] 3197 0
Adverse events following oseltamivir within 4 weeks from commencing course
Timepoint [6] 3197 0
Secondary outcome [7] 3198 0
Duration of each outbreak/time to cessation of outbreak
Timepoint [7] 3198 0
Secondary outcome [8] 3199 0
Quality of life of participants (assessed by EQ-5D) before and 4–6 weeks after onset of the outbreak
Timepoint [8] 3199 0

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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Allocation was concealed through randomised allocation by an independent statistician on recruitment of participating aged-care facilities
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1464 0
Government body
Name [1] 1464 0
Australian Research Council Linkage Grant
Country [1] 1464 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown New South Wales 2006
Country
Australia
Secondary sponsor category [1] 1293 0
Hospital
Name [1] 1293 0
The Children’s Hospital at Westmead
Address [1] 1293 0
Locked Bag 4001, Westmead, NSW 2145
Country [1] 1293 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2844 0
University of Sydney
Ethics committee address [1] 2844 0
Ethics committee country [1] 2844 0
Australia
Date submitted for ethics approval [1] 2844 0
Approval date [1] 2844 0
21/03/2006
Ethics approval number [1] 2844 0
03-2006/3/8446
Ethics committee name [2] 2845 0
The Children’s Hospital at Westmead
Ethics committee address [2] 2845 0
Ethics committee country [2] 2845 0
Australia
Date submitted for ethics approval [2] 2845 0
Approval date [2] 2845 0
29/06/2006
Ethics approval number [2] 2845 0
2006/057

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35156 0
Address 35156 0
Country 35156 0
Phone 35156 0
Fax 35156 0
Email 35156 0
Contact person for public queries
Name 10374 0
Cameron Moffatt
Address 10374 0
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 10374 0
Australia
Phone 10374 0
+61 2 98450121
Fax 10374 0
+61 2 98451418
Email 10374 0
cameronM@chw,edu.au
Contact person for scientific queries
Name 1302 0
Professor Robert Booy
Address 1302 0
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 1302 0
Australia
Phone 1302 0
+61 2 98451415
Fax 1302 0
+61 2 98451418
Email 1302 0
RobertB2@chw.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseNeuraminidase inhibitors for preventing and treating influenza in adults and children.2014https://dx.doi.org/10.1002/14651858.CD008965.pub4
N.B. These documents automatically identified may not have been verified by the study sponsor.