Comparison of Effectiveness in Reducing Severity of Illness in Influenza Pediatric Outpatients Treated With BXM or Neuraminidase Inhibitors - 2018/19, 2019/20 influenza season data
- Conditions
- Influenza virus infection
- Registration Number
- JPRN-UMIN000051678
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 200000
Not provided
1, Patients with an admission receipt or DPC receipt with the date of admission from 90 days before Day 1 2, Patients who have administration dates of an antibacterial drugs from 90 days prior to Day 1 3, Patients who has a diagnosis (no suspicion flag) of pneumonia in receipts for the past 3 months from the month with Day 1 to excluding the month with Day 1, or has a medical starting date before Day 1 to including Day 1 in receipts for the month including Day 1. 4, Patients who have infusions on Day 1 5, Patients with febrile seizures on Day 1 with medical starting date (no suspicion flag) 6, Patients who died on Day 1 (Patients for whom "terminate in death" is described in the disease name in the receipt for the month including Day 1 and whose last date of medical treatment in the receipt is the same as Day 1). 7, Patients under 5 years old or 12 years old or older as of Day 1 8, Patients with multiple influenza anti-influenza drugs (BXM, OTV, ZNV, LNV, or PRV) dispensing dates on Day 1.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospitalization incidence (days 2-14) with the date of diagnosis of influenza infection as Day 1
- Secondary Outcome Measures
Name Time Method Incidence of each of the following events from Day 2 to Day 14 - Antibacterial oral administration - Antibacterial injectable administration - Pneumonia - Additional anti-influenza drug use - Infusion - Febrile seizures - Each secondary end points with hospitalization