E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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) Phenotypic and genotypic analysis of influenza A with respect to neuraminidase inhibitor resistance (c) Subtype analysis of influenza virus isolate
Post treatment samples (a) Virus detection by (i) culture and infectivity and (ii) molecular analysis (b) Determination of IC50 to oseltamivir (c) Phenotypic and genotypic analysis of influenza with respect to neuraminidase inhibitor resistance
Clinical endpoints Duration of symptoms in those subjects, if any, who develop drug resistance compared to those subjects who have no detectable resistant virus
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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study period- during swine influenza outbreaks which are likely to be during Oct 2009- March 2010 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |