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

NCT ID: NCT07177508

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2355 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-07-30

Brief Summary

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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.

Detailed Description

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RSV infection is the leading cause for hospitalisation in young children. Treatment of RSV is primarily supportive, and includes supplemental oxygen therapy, ventilatory support, and fluid management. Prevention of paediatric RSV has been limited to monoclonal antibody (MAB) use for selected high-risk infants: palivizumab, a neutralising antibody against RSV, reduces RSV-related hospitalisation and illness severity in high-risk infants when administered monthly throughout the RSV season. Palivizumab was approved in Australia in 1999, however cost effectiveness has curtailed broad access. A novel long-acting monoclonal antibody, nirsevimab, was approved in Australia in November 2023. A single dose provides protection against RSV for the duration of an RSV season, and it is now recommended in preference to palivizumab. Nirsevimab is funded by individual jurisdictions. The Australian Capital Territory (ACT) commenced a nirsevimab program in April 2024, offered to infants born less than 37 weeks' gestation after 31st October 2023, all Aboriginal and Torres Strait Islander babies born after 31st October 2023, and infants with specific medical conditions.

This study aims to describe and compare the incidence of RSV infection, RSV-related ED presentations and hospital admissions, and severity of illness in children \<2 years in the ACT, pre- and post- nirsevimab introduction. he pre-nirsevimab period will be defined as 1/4/2022 to 31/3/2024 and the post-nirsevimab period 1/4/2024 to 31/3/2025.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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RSV cases

Children under 2 years of age with laboratory confirmed RSV infection

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* child aged less than 2 years
* laboratory confirmed RSV

Exclusion Criteria

* n/a
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nicola Irwin

OTHER

Sponsor Role lead

Responsible Party

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Nicola Irwin

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Canberra Hospital

Garran, Australian Capital Territory, Australia

Site Status

Countries

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Australia

Other Identifiers

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2024.LRE.00283

Identifier Type: -

Identifier Source: org_study_id

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