Influenza A
Conditions
Interventions
Trade Name: tamiflu suspension
Product Name: Tamiflu
Pharmaceutical Form: Oral suspension
Sponsors
University Hospitals Leicester, Leicester General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: ; 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 | — |
Countries
United Kingdom
Outcome results
None listed