First Year Impact of Nirsevimab on Paediatric Respiratory Syncytial Virus Infection and Hospitalisations in the Australian Capital Territory

NCT07177508 | Completed

• 1 other identifier: 2024.LRE.00283
• Study Type: observational
• Target: 2,355
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to explore the impact of a new prevention medicine (nirsevimab) on the burden of Respiratory Syncytial Virus (RSV) disease in children under 2 years of age. The main question it aims to answer is: How has the incidence of RSV, and Emergency Department presentations and hospital admissions for RSV-related disease changed since nirsevimab was introduced? Participants won't need to do anything extra for this research study, as only routinely collected data will be used for analysis.

Conditions

Respiratory Syncytial Viral (RSV) Infection; Respiratory Syncytial Virus Hospitalizations; Respiratory Syncytial Virus Prevention

Keywords

Epidemiological Methods; Infections

Outcome Measures

Primary Outcomes (3)

• RSV hospitalisation

  RSV-related hospital admissions will be determined by reviewing hospital admissions occurring within one month of a positive RSV test. The discharge summary will be reviewed for a diagnosis or other clinical information consistent with RSV-related illness (bronchiolitis, respiratory tract infection, viral illness), and cross-checked with the ICD-10-AM coding for the episode.

  Over a period of 3 years

• RSV cases

  RSV cases will be determined by laboratory notifications of positive RSV infection on PCR test to ACT Health, the body responsible for receiving notifiable disease notifications.

  Over a period of 3 years

• Emergency Department presentations

  RSV-related ED presentations will be determined by reviewing ED presentations occurring within one month of a positive RSV test. Documentation from the presentation will be reviewed for a discharge diagnosis or impression consistent with RSV-related illness (bronchiolitis, respiratory tract infection, viral illness). If no discharge letter or doctors' documentation is available, the triage note will be reviewed for a presenting complaint consistent with RSV-related illness (rhinorrhoea, nasal congestion, cough, respiratory distress, diffuse crackles and/or wheeze, fever, hypoxaemia, and associated feeding difficulties, vomiting, dehydration, or lethargy).

  Over a period of 3 years

Study Arms (1)

RSV cases

Children under 2 years of age with laboratory confirmed RSV infection

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study is set in the Australian Capital Territory, a small Australian jurisdiction with a single acute paediatric service provider.

You may qualify if:

• child aged less than 2 years
• laboratory confirmed RSV

You may not qualify if:

• n/a

Sponsors & Collaborators

• Nicola Irwin: lead

Study Sites (1)

The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

MeSH Terms

Conditions

Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: December 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From 3 months after publication of results to 3 years.
• Access Criteria: Researchers with a methodologically sound proposal, subject to ethics and governance processes. A data sharing agreement will be required.

Locations

AU (1)