ANZCTR - Registration

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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]

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

Condition category

Condition code

Respiratory

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]

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]

Attack rate of influenza in staff/residents of an aged-care facility in an outbreak

Timepoint [1]

Secondary outcome [1]

Death within 4 weeks from onset of influenza symptoms of patient & case fatality rate within 4 weeks from onset of the outbreak

Timepoint [1]

Secondary outcome [2]

Pneumonia incidence within 4 weeks from onset of influenza symptoms of patient

Timepoint [2]

Secondary outcome [3]

Hospital admission incidence within 4 weeks from onset of influenza symptoms of patient

Timepoint [3]

Secondary outcome [4]

Staff absenteeism during the outbreak

Timepoint [4]

Secondary outcome [5]

Development of oseltamivir resistant influenza during the course of treatment or prophylaxis

Timepoint [5]

Secondary outcome [6]

Adverse events following oseltamivir within 4 weeks from commencing course

Timepoint [6]

Secondary outcome [7]

Duration of each outbreak/time to cessation of outbreak

Timepoint [7]

Secondary outcome [8]

Quality of life of participants (assessed by EQ-5D) before and 4–6 weeks after onset of the outbreak

Timepoint [8]

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?

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]

Government body

Name [1]

Australian Research Council Linkage Grant

Address [1]

GPO Box 2702
CANBERRA
ACT 2601
AUSTRALIA

Country [1]

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]

Hospital

Name [1]

The Children’s Hospital at Westmead

Address [1]

Locked Bag 4001, Westmead, NSW 2145

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/03/2006

Ethics approval number [1]

03-2006/3/8446

Ethics committee name [2]

The Children’s Hospital at Westmead

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

29/06/2006

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Cameron Moffatt

Address

National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61 2 98450121

Fax

+61 2 98451418

cameronM@chw,edu.au

Contact person for scientific queries

Name

Professor Robert Booy

Address

National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61 2 98451415

Fax

+61 2 98451418

[email protected]

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.

Trial Review

Documents added manually

Documents added automatically