None listed
Conditions
Brief summary
This study will assess the frequency of emergence of oseltamivir resistant viruses, and their virological characteristics, in patients treated with standard and double dose oseltamivir for influenza caused by A/H1N1 2009 (‘swine flu’) and other human influenza viruses. Patients with clinical symptoms indicative of influenza, who present within 48 hours of the onset of fever during confirmed influenza activity in the community, will be randomised to receive immediate treatment with oseltamivir at a standard age appropriate dose or a double dose, twice daily for 5 days. Patients will have baseline virus samples taken for typing and oseltamivir sensitivity and also on day 5 of treatment.
Interventions
The main purpose of this study is to assess the frequency of emergence of oseltamivir resistant viruses, and their virological characteristics, in patients treated with standard and double dose oseltamivir (oral capsules or suspension) 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.
This is an unblinded randomized study. Patients with clinical symptoms indicative of infl
The main purpose of this study is to assess the frequency of emergence of oseltamivir resistant viruses, and their virological characteristics, in patients treated with standard and double dose oseltamivir (oral capsules or suspension) 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. This is an unblinded randomized study. Patients with clinical symptoms indicative of influenza, who present within 48 hours of the onset of fever during confirmed influenza activity in the community, will be randomized to receive immediate treatment with oseltamivir at a standard age-appropriate dose or a double dose, twice daily for 5 days. Patients will have baseline virus samples taken for typing and oseltamivir sensitivity and also on day 5 of treatment.
Sponsors
National Centre for Immunisation Research and Surveillance (NCIRS)
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 No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following inclusion criteria to participate in this study: 1. The age of the patient is at least 5 years. 2. The patient has a positive rapid antigen test for influenza A and symptoms indicative of influenza that have lasted no more than 48 hours: - fever >= 37.8 celsius and - at least one respiratory symptom (cough, coryza, sore throat, rhinitis)
Exclusion criteria
If one or more of the following criteria are met, the participant will be ineligible to take part in this study: 1. Clinical suspicion of infection with a respiratory virus other than influenza. 2. Suspicion of invasive bacterial infection requiring immediate admission to hospital. 3. Evidence of a poorly controlled underlying medical condition. 4. Known immunosuppression (malignancy, transplant, drugs) 5. Pregnant or lactating females 6. Known allergy to oseltamivir. 7. Participation in another clinical trial with an investigational drug. 8. Participant with insufficient English language skills. 9. A person about whom the investigator thinks that the person is unlikely to comply with the study requirements.
Outcome results
None listed