RecruitingPhase 4ACTRN12606000278538

Economic and Social Benefits of Treating and Preventing Influenza in Aged Care Facilities

Sponsor

The University of Sydney

Enrollment

3,200 participants

Start Date

Jun 30, 2006

Study Type

Interventional

Conditions

Influenza outbreak in an aged-care facility

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing two different approaches for controlling influenza (flu) outbreaks in aged care facilities. One approach is to treat people who get sick with the antiviral drug oseltamivir (Tamiflu). The other is to treat sick people AND also give the drug to well residents and staff who have been exposed to the flu, to prevent them from getting sick. The study aims to find out which approach better controls outbreaks and saves costs. You may be eligible if: - You are 18 years or older - You are a resident, staff member, volunteer, or regular carer at a participating aged care facility during a flu outbreak You may NOT be eligible if: - You have a medical reason that prevents you from taking oseltamivir - You are a pregnant staff member, volunteer, or carer - You are on dialysis for kidney disease or your kidney function is very low - You have had flu symptoms for more than 48 hours (for the treatment part of the study) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.

Locations(1)

Australia

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ACTRN12606000278538