RecruitingPhase 4ACTRN12610000361000

An unblinded randomized study of influenza A/H1N1 2009 (swine flu)resistance under standard and extended duration Oseltamivir treatment

An unblinded randomised study to evaluate viral resistance (viral shredding) following standard and extended duration Oseltamivir treatment in patients with influenza A/H1N1 2009


Sponsor

Roche Products NZ Ltd

Enrollment

125 participants

Start Date

Aug 5, 2009

Study Type

Interventional

Conditions

Summary

The study will show whether the influenza virus is more likely to develop resistance to Tamiflu during treatment while using a standard 5 day course compared with an extended 10 day course.


Eligibility

Sex: Both males and femalesMin Age: 5 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing a standard 5-day course of Tamiflu (oseltamivir) against a 10-day course to see which is less likely to allow the influenza virus to develop resistance to the drug. Tamiflu is commonly used to treat swine flu (H1N1) and other influenza strains. Researchers are concerned that shorter treatment courses might allow the virus to mutate and become resistant, making the drug less effective in the future. You may be eligible if: - You are 5 years or older - You have tested positive for influenza A (or your doctor strongly suspects it based on symptoms) - You have a fever of 37.8°C or higher, or had one within the last 24 hours - You have at least one respiratory symptom such as cough, sore throat, or runny nose - Your symptoms started no more than 48 hours before being seen - Women of childbearing age must be using adequate contraception You may NOT be eligible if: - You are pregnant or breastfeeding - You have severe breathing problems - You have serious COPD, advanced heart failure, or significant kidney disease - You are immunocompromised or have HIV - You are currently being treated for hepatitis B or C - You have a known allergy to oseltamivir (Tamiflu) 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

Adults or subjects >40 kg will be randomised in a ratio of 1:1 to a standard 75mg twice a day for 5 days or an extended 75mg tiwice a day for 10 days. The mode of adminstration is an oral capsule Chi

Adults or subjects >40 kg will be randomised in a ratio of 1:1 to a standard 75mg twice a day for 5 days or an extended 75mg tiwice a day for 10 days. The mode of adminstration is an oral capsule Children will be randomised in a ratio of 1:1 to a standard dose for 5 days or an extended dose for 10 days powder for oral suspension, which when reconstituted with water to a concentration of 1.2% contains 12 mg/mL oseltamivir. The dose is calculated by weight. 15 kg or less 60 mg per day divided into 2 doses 15–23 kg 90 mg per day divided into 2 doses 24–40 kg 120 mg per day divided into 2 doses


Locations(1)

New Zealand

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ACTRN12610000361000