Bronchiolitis, ViralENVIENCT06030505
Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis
An observational study of Bronchiolitis, Viral, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Bronchiolitis, Viral
- How many people
- 1,140 participants
- Where
- 5 sitesFrance
- Study dates
- 15 Oct 2023to 29 Dec 2023
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Paediatric patients under 12 months of age treated for RSV bronchiolitis (for cases), or for one of the conditions listed in the inclusion criteria (for controls).
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Refusal to participate by the patient, their relative or legal representative
- Administration of Palivizumab.
- Maternal vaccination against RSV.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Bondy - Jean Verdier
Bondy
CHI Créteil
Créteil
Hôpital Armand Trousseau AP-HP
Paris, 75012
CHU Robert-Debré
Paris
CHU Toulouse-hôpital des Enfants
Toulouse
About this study
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.
- Conditions
- Bronchiolitis, Viral
- Being tested
- No intervention required by the protocol
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention required by the protocolOther
No visits or samples will be taken specifically for this study. This research involves only prospective or retrospective data collection in relation to the usual hospital management of the child included. Similarly, patient follow-up will be strictly within the framework of their usual hospital care in relation to their pathology.
| Study group | Role | What they receive |
|---|---|---|
| Case patients | Collection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research. Receives: Other: No intervention required by the protocol | |
| Control patients | Collection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research. Receives: Other: No intervention required by the protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients passively immunised with nirsevimab
Proportion of patients passively immunised with nirsevimab in children hospitalised with RSV bronchiolitis and in the control group
Measured: 7 days
Secondary outcomes (5)
Proportion of hospitalised children for RSV bronchiolitis requiring invasive or non-invasive ventilatory passively immunised with nirsevimab
Proportion of children passively immunised with nirsevimab hospitalised for bronchiolitis requiring invasive or non-invasive ventilatory support, including RSV bronchiolitis
Measured: 7 days
Length of hospital stay
Length of hospital stay for children with RSV bronchiolitis.
Measured: 7 days
Time immunisation
Time between immunisation with nirsevimab and hospitalisation for RSV bronchiolitis.
Measured: 7 days
Frequency of hospital admissions
Monthly frequency of hospital admissions for RSV bronchiolitis among participating centres over time
Measured: 7 days
Proportion of children hospitalised for RSV bronchiolitis with viral co-detection
Proportion of children hospitalised for RSV bronchiolitis with viral co-detection or viral detection other than RSV on nasopharyngeal swab
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start15 Oct 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis, ViralStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030505
- Sponsor's protocol ID
- ENVIE
- Other IDs
- 2023-A01803-42
- Acronym
- ENVIE
- Status last verified
- Apr 2024
- First submitted
- 24 Aug 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Assad Z, Romain AS, Aupiais C, Shum M, Schrimpf C, Lorrot M, Corvol H, Prevost B, Ferrandiz C, Giolito A, Valtuille Z, Bendavid M, Cohen JF, Toubiana J, de Pontual L, Delande CF, Levy M, See P, Cohen R, Levy C, Angoulvant F, Lenglart L, Gits-Muselli M, Biran V, Diallo K, Alemede O, El Hebil MM, Durrmeyer X, Labouret G, Casanovas N, Hallak B, Marechal O, Jung C, Brehin C, Ouldali N. Nirsevimab and Hospitalization for RSV Bronchiolitis. N Engl J Med. 2024 Jul 11;391(2):144-154. doi: 10.1056/NEJMoa2314885.
PubMed 38986058
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis
- ClinicalTrials.gov ID
- NCT06030505
- Acronym / sponsor ID
- ENVIE / ENVIE
- Conditions
- Bronchiolitis, Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,140 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 11 Sep 2023 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case patients | – | Other: No intervention required by the protocolCollection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research. |
| Control patients | – | Other: No intervention required by the protocolCollection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Paediatric patients under 12 months of age treated for RSV bronchiolitis (for cases), or for one of the conditions listed in the inclusion criteria (for controls).
Key inclusion criteria (15 listed)
- Children under 12 months of age
- Treated for acute RSV bronchiolitis
- Hospitalised following a visit to the paediatric emergency department
- 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
Key exclusion criteria (3 listed)
- Refusal to participate by the patient, their relative or legal representative
- Administration of Palivizumab.
- Maternal vaccination against RSV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention required by the protocolNo visits or samples will be taken specifically for this study. This research involves only prospective or retrospective data collection in relation to the usual hospital management of the child included. Similarly, patient follow-up will be strictly within the framework of their usual hospital care in relation to their pathology. | Other | Case patients, Control patients |
Primary outcome
Proportion of patients passively immunised with nirsevimab
Time frame: 7 days
Proportion of patients passively immunised with nirsevimab in children hospitalised with RSV bronchiolitis and in the control group
5 secondary outcomes
Proportion of hospitalised children for RSV bronchiolitis requiring invasive or non-invasive ventilatory passively immunised with nirsevimab
Time frame: 7 days
Length of hospital stay
Time frame: 7 days
Time immunisation
Time frame: 7 days
Frequency of hospital admissions
Time frame: 7 days
Proportion of children hospitalised for RSV bronchiolitis with viral co-detection
Time frame: 7 days
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 29 Aug 2025.
- Derived from this study: PubMed 38986058Assad Z, Romain AS, Aupiais C, Shum M, Schrimpf C, Lorrot M, Corvol H, Prevost B, Ferrandiz C, Giolito A, Valtuille Z, Bendavid M, Cohen JF, Toubiana J, de Pontual L, Delande CF, Levy M, See P, Cohen R, Levy C, Angoulvant F, Lenglart L, Gits-Muselli M, Biran V, Diallo K, Alemede O, El Hebil MM, Durrmeyer X, Labouret G, Casanovas N, Hallak B, Marechal O, Jung C, Brehin C, Ouldali N. Nirsevimab and Hospitalization for RSV Bronchiolitis. N Engl J Med. 2024 Jul 11;391(2):144-154. doi: 10.1056/NEJMoa2314885.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis, Viral, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
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 15 inclusion and 3 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 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Proportion of patients passively immunised with nirsevimab (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06030505, which also lists 1 linked publication.
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 29 Aug 2025.