Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses

Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses - Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038553

Enrollment

200

Registered

2019-11-12

Start date

2019-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza type A or B virus infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with influenza A or B virus infection who are able to visit the hospital again between 4 and 6 days after starting Tamiflu treatment

Exclusion criteria

Exclusion criteria: No criteria

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
(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).	—

Measure

Time frame

(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).

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Countries

Japan

Contacts

Public ContactRyousuke Harada

Chugai Pharmaceutical Co. Ltd. Safety Science Dept.

haradarus@chugai-pharm.co.jp03-3281-6611

Outcome results