Influenza
Conditions
Interventions
Trade Name: TAMIFLU
Product Name: TAMIFLU
Pharmaceutical Form: Capsule, hard
Trade Name: TAMIFLU
Product Name: TAMIFLU
Pharmaceutical Form: Oral suspension
Trade Name: RELENZA (zanamivir)
Product Na
Sponsors
University Hospitals Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Boys and girls must satisfy the following to qualify for the study:aged between >1 and 16 years (or any age eligible for treatment)and have Parents or legal guardians willing to give written informed consent 2. Subjects aged over 16 years: AND 3. presenting an acute febrile illness including o acute respiratory tract illness, o febrile seizure o febrile gastrointestinal illness o acute febrile illness with temp >38oC 4. Willing for post treatment sampling to be conducted 5. Able to adhere with oseltamivir treatment (5 days b.d dosing) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria • unable to obtain informed consent • conditions presenting with: o rash o known bacterial aetiology o non-respiratory conditions with known aetiology • allergy to oseltamivir or zanamivir • presence of underlying condition requiring dose alteration of oseltamivir e.g. severe renal failure • Concomitant therapy requiring oseltamivir dose alteration including methotrexate and probenecid • inability to obtain nasopharyngeal sample for analysis • concurrent enrollment in any therapeutic intervention studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What is the purpose of the study? Influenza is a serious cause of respiratory infection, particularly in children. Flu comes around in winter seasons in most years, but occasionally new influenza viruses appear and cause pandemics of flu which is happening with the swine influenza virus. We do not know much about the new swine flu- most important we don’t know how long it stays in the nose and how long patients are potentially infective to others Some drugs are available for treatment of influenza. One of these is called ‘Tamiflu’. Clinical trials have proved that Tamiflu can be safely used to reduce the duration and severity of influenza, provided that it is given early. Tamiflu is licenced for use in children in many countries around the world including the UK. Another drug is called ‘Relenza’ which is given by an inhaler and may not be easily used in young children or adults. It is important to know if flu viruses can become resistant to these drugs. In the Relenza and T;Secondary Objective: ;Primary end point(s): This is an observational study. We will be assessing the frequency of phenotypic and genotypic resistance to antivirals in pre and post treatment nasal secretions. We calculate that 100 subjects would need to be studied to detect resistance of 20% at power 80% with alpha0.05 Household transmission This is an exploratory study and not powered to detect statistical differences in transmission rates between drug resistant and wildtype strains. Observational analysis Although the study is not powered to evaluate statistical differences in clinical symptoms between two possible clinical groups (i.e. those subjects in whom viral resistance emerges in post treatment samples, and those in whom this does not); we will analysis any differences in clinical duration of symptoms following treatment by comparative methods. Endpoints are primarily laboratory endpoints Laboratory Pre treatment samples (a) Baseline IC50 to oseltamivir (b) Ph | — |
Countries
United Kingdom
Outcome results
None listed