A prospective observational study to evaluate the relationship between adherence to anti-influenza medication and effectiveness in pediatric influenza patients

A prospective observational study to evaluate the relationship between adherence to anti-influenza medication and effectiveness in pediatric influenza patients - A prospective observational study to evaluate the relationship between adherence to anti-influenza medication and effectiveness in pediatric influenza patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053258

Enrollment

3000

Registered

2024-01-05

Start date

2024-01-09

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 virus infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who can provide consent for clinical research participation from their parent or legal guardian. In addition, informed assent should be obtained from the patient as much as possible. 2. Pediatric influenza patients aged 6 -11 years. 3. Patients diagnosed with influenza virus infection and prescribed anti-influenza medication. 4. Patients who can be expected to take medication within 2 days of the onset of influenza.

Exclusion criteria

Exclusion criteria: 1. Patients who refuse to participate in the study

Design outcomes

Primary

Measure	Time frame
Duration of influenza illness from the first administration of medication to resolution Influenza illness: fever (37.5 or higher than 37.5 degree Celsius), cough or nasal congestion/runny nose	—

Secondary

Measure	Time frame
- Number of days from the first administration of medication to the return of normal body temperature (below 37.5 degree Celsius) - Number of days from the first administration of medication to the resolution of each of the 7 influenza symptoms ("cough", "sore throat", "headache", "nasal congestion/runny nose", "feeling feverish/chills", "muscle or joint pain", "fatigue") - Number of days from the first administration of medication to the resolution of all influenza symptoms - Presence or absence of influenza symptoms ("cough", "nasal congestion/runny nose", "body temperature") on day 5 of medication - Presence or absence of antipyretic effect (return to normal body temperature below 37.5 degree Celsius) on day 5 of medication - Presence or absence of any of the 7 influenza symptoms ("cough", "sore throat", "headache", "nasal congestion/runny nose", "feeling feverish/chills", "muscle or joint pain", "fatigue") on day 5 of medication - Presence or absence of each influenza symptom on day 5 of medication - Presence or absence of influenza-related complications (pneumonia, bronchitis, sinusitis, otitis media, influenza encephalopathy or encephalitis, febrile seizures, myositis) - Hospitalization status - Compliance rate of medication adherence and breakdown of reasons for difficulties in adherence	—

Measure

Time frame

- Number of days from the first administration of medication to the return of normal body temperature (below 37.5 degree Celsius) - Number of days from the first administration of medication to the resolution of each of the 7 influenza symptoms ("cough", "sore throat", "headache", "nasal congestion/runny nose", "feeling feverish/chills", "muscle or joint pain", "fatigue") - Number of days from the first administration of medication to the resolution of all influenza symptoms - Presence or absence of influenza symptoms ("cough", "nasal congestion/runny nose", "body temperature") on day 5 of medication - Presence or absence of antipyretic effect (return to normal body temperature below 37.5 degree Celsius) on day 5 of medication - Presence or absence of any of the 7 influenza symptoms ("cough", "sore throat", "headache", "nasal congestion/runny nose", "feeling feverish/chills", "muscle or joint pain", "fatigue") on day 5 of medication - Presence or absence of each influenza symptom on day 5 of medication - Presence or absence of influenza-related complications (pneumonia, bronchitis, sinusitis, otitis media, influenza encephalopathy or encephalitis, febrile seizures, myositis) - Hospitalization status - Compliance rate of medication adherence and breakdown of reasons for difficulties in adherence

—

Countries

Japan

Contacts

Public ContactMasayuki Kobayashi

Shionogi & Co., Ltd. Data Science Department

masayuki.kobayashi@shionogi.co.jp080-8502-5720

Outcome results