JRCT ID: jRCT1040240081
Registered date:31/08/2024
Study of the effects of nirsevimab on children
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Acute Respiratory Infection |
| Date of first enrollment | 31/08/2024 |
| Target sample size | 10000 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | [1] Number of patients with acute respiratory infection hospitalized at collaborating inpatient pediatric institutions by age group (a) Number of patients hospitalized for acute respiratory infection per 100,000 population (b) Number of deaths due to acute respiratory infection per 100,000 population [2] Of the above, the number of patients with RSV (a) Number of patients hospitalized for RSV infection per 100,000 population (b) Incidence of hospitalizations associated with RSV infection requiring oxygen therapy (per 100,000 population) (c) Incidence of hospitalizations associated with RSV infection requiring mechanical ventilation (per 100,000 population) (d) Incidence of deaths on admission/during hospitalization associated with RSV infection (per 100,000 population) (to evaluate causal relationship to RSV infection) (e) Age groups are classified in the same manner as the infection trends survey |
|---|---|
| Secondary Outcome | [1] Number of patients with acute respiratory infection hospitalized at collaborating outpatient pediatric institutions by age group (a) Number of reports per sentinel sites (b) Number of patients per 100,000 population based on the estimation method of sentinel surveillance (estimated using the total number of outpatients) [2] Of the above, the number of cases diagnosed with RSV by age group, the number of RSV rapid antigen tests, and the number of positive tests (positive rate) (a) Number of reports per sentinel sites (b) Number of patients per 100,000 population based on the estimation method of sentinel surveillance (estimated using the total number of outpatients) (c) RSV rapid test positive rate |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | < 5age old |
| Gender | Both |
| Include criteria | Children younger than 5 years old who visited sentinel medical institution in Mie Prefecture or were admitted to an inpatient medical institution |
| Exclude criteria | Persons 5 years old or older in Mie Prefecture |
Related Information
| Primary Sponsor | Taniguchi Kiyosu |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Sanofi,AstraZeneca |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Shingo Mitsushima |
| Address | 2-174 Edobashi, Tsu-shi, Mie Mie Japan 514-8507 |
| Telephone | +81-59-231-5012 |
| mitsushima@med.mie-u.ac.jp | |
| Affiliation | Mie University Graduate School of Medicine |
| Scientific contact | |
| Name | Kiyosu Taniguchi |
| Address | 357, Ozato Kubotacho, Tsu Shi, Mie Mie Japan 514-0125 |
| Telephone | +81-59-232-2531 |
| tngk7g04@gmail.com | |
| Affiliation | National Hospital Organization Mie Hospital |