Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses
Not Applicable
Recruiting
- Conditions
- Influenza type A or B virus infection
- Registration Number
- JPRN-UMIN000038553
- Lead Sponsor
- Chugai Pharmaceutical Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
No criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of influenza viruses A neuraminidase activity assay is performed to quantitatively assess sensitivity to oseltamivir (as expressed by IC50) using the isolated viral neuraminidase of isolated and identified influenza viruses. If sensitivity (as expressed by IC50) is reduced (increased IC50), the neuraminidase and hemagglutinin genes of the isolated virus are analyzed. - Sensitivity by influenza virus type. - Rate of influenza virus resistance and its 95% confidence interval. - Variation in sensitivity will be considered. - Variation in neuraminidase and hemagglutinin amino acids will be considered.
- Secondary Outcome Measures
Name Time Method (1)Efficacy (1-1)Duration of pyrexia:to For patients with body temperature over 37.8 immediately before taking Tamiflu, the period from the time when Tamiflu treatment started to the time when body temperature Decreased to under 36.9 (in chidren, under 37.4). However, when comparing to data from the development phase, patients with body temperature over 38.0 immediately before taking Tamiflu will be considered. (1-2)Duration of symptoms: For patients in whom influenza symptoms were classified as Moderate or Severe immediately before taking Tamiflu, the period from the time when Tamiflu treatment started to the time when all influenza symptoms became Absent or Mild. (2)Safety Incidences of adverse events and adverse drug reactions (by SOC and symptom).