An Unblinded Randomized Study of Influenza A/H1N1 2009 (Swine flu)Resistance to Oseltamivir and Zanamivir

Phase 4

Recruiting

• Conditions: Influenza; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12609000906257
• Lead Sponsor: Prof Robert Booy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. The age of the patient is at least 5 years to upper limit of 50 years.
2. The patient has a positive rapid antigen test for influenza A or B and symptoms indicative of influenza that have
lasted no more than 72 hours:
a. fever 37.8 degree celsius or subjective fever and
b. at least one respiratory symptom (cough, coryza, sore throat, rhinitis)

Exclusion Criteria

1. Suspicion of invasive bacterial infection requiring immediate admission to hospital.
2. Evidence of a poorly controlled underlying medical condition.
3. Known immunosuppression (malignancy, transplant, drugs).
4. Pregnant or lactating females
5. Known allergy to oseltamivir or zanamivir.
6. Participation in another clinical trial with an investigational drug.
7. Participant with insufficient English language skills.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Frequency of isolation of resistant virus in subjects aged 5 years or greater[01/08/2009-31/12/2009]

Secondary Outcome Measures

Name	Time	Method
1. Reductions in viral load after 5 days of treatment<br>2. Correlation of viral load with clinical outcome (signs and symptoms) after 5 days of treatment[01/08/2009 to 31/12/2010]