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 |
To examine the frequency of influenza virus resistance to oseltamivir after treatment of acute influenza A infection in children using a weight unit based dosing regimen of oseltamivir when assessed by molecular cloning and sequencing of post-treatment viral quasi-species in comparison to standard phenotypic IC50 determination.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria
Boys and girls must satisfy the following to qualify for the study: 1. Aged between >1 and 12 years 2. Parents or legal guardians willing to give written informed consent 3. Presenting within 48 hours of onset of an acute febrile illness including acute respiratory tract illness, febrile seizure, febrile gastrointestinal illness, 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 with paediatric suspension)
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E.4 | Principal exclusion criteria |
Exclusion criteria 1. unable to obtain informed consent 2. conditions presenting with: rash, known bacterial aetiology, non-respiratory conditions with known aetiology, allergy to oseltamivir 3. presence of underlying condition requiring dose alteration of oseltamivir e.g. severe renal failure 4. Concomitant therapy requiring oseltamivir dose alteration including methotrexate and probenecid 5. inability to obtain nasopharyngeal sample for analysis 6. concurrent enrollment in any therapeutic intervention studies
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E.5 End points |
E.5.1 | Primary end point(s) |
Laboratory endpoints
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 A 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 A with respect to neuraminidase inhibitor resistance
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
assessment of frequency of resistance emerging after treatment with antiviral drug (oseltamivir) |
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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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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) | No |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | Information not present in EudraCT |
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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Nasal specimen on Day 9 taken following treatment with oseltamivir |
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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 | |