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

An Unblinded Randomized Study of Influenza A/H1N1 2009 Resistance to Oseltamivir and Zanamivir

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000906257

Enrollment

120

Registered

2009-10-20

Start date

2009-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main purpose of this study is to assess the frequency of emergence of oseltamivir and zanamivir resistant influenza viruses, and their virological characteristics, in patients treated with oseltamivir and zanamivir for influenza caused by A/H1N1 2009 (‘swine flu’) and other human influenza viruses during periods of high transmission. Limited clinical information will also be collected. Patients with clinical symptoms indicative of influenza, who present within 72 h of the onset of fever during confirmed influenza activity in the community, will be randomized to receive immediate treatment with oseltamivir or zanamivir according to standard age appropriate dose. Patients will have baseline virus samples taken for typing and oseltamivir and zanamivir sensitivity and also on completion of treatment (After 5 days of treatment). Limited clinical information will also be collected.

Interventions

Patients with clinical symptoms indicative of influenza, who present within 72 h of the onset of fever during confirmed influenza activity in the community and have a positive rapid antigen test for influenza; will be randomized to receive immediate treatment with oseltamivir or zanamivir according to standard age appropriate dose. Standard Oseltamivir and Zanamivir treatment in influenza is given as twice daily doses for 5 days. Mode of administration: Oseltamivir- Capsule, Suspension Zanamivi

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to 50 Years

Healthy volunteers

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.

Outcome results