Respiratory Syncytial Viral (RSV) InfectionNCT07177508
First Year Impact of Nirsevimab on Paediatric Respiratory Syncytial Virus Infection and Hospitalisations in the Australian Capital Territory
An observational study of Respiratory Syncytial Viral (RSV) Infection and Respiratory Syncytial Virus Hospitalizations, run by Nicola Irwin at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Respiratory Syncytial Viral (RSV) Infection, Respiratory Syncytial Virus Hospitalizations, Respiratory Syncytial Virus Prevention
- How many people
- 2,355 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2024to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: The study is set in the Australian Capital Territory, a small Australian jurisdiction with a single acute paediatric service provider.
Who may be able to join
- child aged less than 2 years
- laboratory confirmed RSV
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Canberra Hospital
Garran, Australian Capital Territory, 2605
About this study
Official title: First Year Impact of Nirsevimab on Paediatric Respiratory Syncytial Virus Infection and Hospitalisations in the Australian Capital Territory: An Observational Study
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.
Read the detailed description
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
- Respiratory Syncytial Viral (RSV) Infection, Respiratory Syncytial Virus Hospitalizations, Respiratory Syncytial Virus Prevention
- Keywords
- Epidemiological Methods, Infections
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RSV cases | Children under 2 years of age with laboratory confirmed RSV infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Over a period of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Dec 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Viral (RSV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicola Irwin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicola Irwin, The Canberra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177508
- Sponsor's protocol ID
- 2024.LRE.00283
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD that underlie any published results may be shared upon reasonable request, and subject to ethics and governance processes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Year Impact of Nirsevimab on Paediatric Respiratory Syncytial Virus Infection and Hospitalisations in the Australian Capital Territory: An Observational Study
- ClinicalTrials.gov ID
- NCT07177508
- Acronym / sponsor ID
- 2024.LRE.00283
- Conditions
- Respiratory Syncytial Viral (RSV) Infection, Respiratory Syncytial Virus Hospitalizations, Respiratory Syncytial Virus Prevention
- Keywords
- Epidemiological Methods, Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,355 participants (actual)
- Lead sponsor
- Nicola IrwinUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSV cases | – | –Children under 2 years of age with laboratory confirmed RSV infection |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study is set in the Australian Capital Territory, a small Australian jurisdiction with a single acute paediatric service provider.
Key inclusion criteria (2 listed)
- child aged less than 2 years
- laboratory confirmed RSV
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RSV hospitalisation
Time frame: Over a period of 3 years
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.
RSV cases
Time frame: Over a period of 3 years
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.
Emergency Department presentations
Time frame: Over a period of 3 years
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes. Deidentified IPD that underlie any published results may be shared upon reasonable request, and subject to ethics and governance processes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Viral (RSV) Infection and Respiratory Syncytial Virus Hospitalizations, run by Nicola Irwin at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSV hospitalisation (time frame: Over a period of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.