Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis (NCT06030505) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis
France1,140 participantsStarted 2023-10-15
Plain-language summary
Respiratory tract infections caused by respiratory syncytial virus (RSV) are a worldwide burden and represent a major public health issue. In France, bronchiolitis is responsible for around 100,000 emergency room visits and 50,000 hospital admissions every year; 75% of infants hospitalised for RSV bronchiolitis are healthy full-term children.
Recent discoveries concerning the specific viral epitopes of RSV have made it possible to move from an empirical approach to a targeted preventive or curative approach (monoclonal antibodies, vaccines, anti-viral drugs).
Nirsevimab is a monoclonal antibody against RSV with enhanced neutralising activity and a prolonged half-life. A randomised, placebo-controlled phase III trial demonstrated the effectiveness of nirsevimab in reducing lower respiratory tract infections caused by RSV requiring medical management in healthy premature and term infants, with a favourable safety profile. The US Food and Drug Administration (FDA) approved the first RSV vaccine on May 3, 2023, and the second was approved on May 31, 2023. Nirsevimab was approved by the European Medicines Agency (EMA) on November 4, 2022.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Cases :
* Children under 12 months of age
* Treated for acute RSV bronchiolitis
* Hospitalised following a visit to the paediatric emergency department
Controls :
* Children under 12 months
* Hospitalised in the conventional sector or in a short-stay hospital unit, or having consulted a paediatric emergency department for one of the following reasons
* Febrile urinary tract infection, without acute ear, nose, and throat (ENT) or respiratory symptoms
* Acute gastroenteritis, without acute ENT or respiratory symptoms
* Infant colic without fever, without ENT or acute respiratory symptoms
* Stagnant weight or feeding difficulties without fever, acute ENT or respiratory symptoms
* Neonatal jaundice without fever or acute ENT or respiratory symptoms
* Unexplained crying without fever, without ENT or acute respiratory symptoms
* Head injury, without acute ENT or respiratory symptoms
* Patient hospitalised for acute surgery without fever, without ENT or acute respiratory symptoms
Exclusion Criteria:
* Refusal to participate by the patient, their relative or legal representative
* Administration of Palivizumab.
* Maternal vaccination against RSV.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients passively immunised with nirsevimab