Prospective study to assess the emergence of drug resistance to oseltamivir following treatment of acute influenza A among children - Oseltamivir resistance study
- Conditions
- Influenza A
- Registration Number
- EUCTR2005-005239-80-GB
- Lead Sponsor
- niversity Hospitals Leicester, Leicester General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method