A prospective study to assess emergence and transmissibility of drug resistance to neuraminidase inhibitor following treatment of children and adults with acute pandemic influenza - antiviral resistance to influenza
- Conditions
- Influenza
- Registration Number
- EUCTR2009-012876-29-GB
- Lead Sponsor
- niversity Hospitals Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
oacute respiratory tract illness,
ofebrile seizure
ofebrile gastrointestinal illness
oacute 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
•unable to obtain informed consent
•conditions presenting with:
orash
oknown bacterial aetiology
onon-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
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