Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)ENVIEANCILLAIRNCT07698769
ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment
An observational study of Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines), run by Centre Hospitalier Intercommunal Creteil at 3 sites in France.
Trial summary
Among children aged ≤ 6 months included in the ENVIE study, the ENVIE_ancillaire study will be offered to cases of RSV infection or to controls. The study involves a nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip sample (dextro type). Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)
- What is being tested?
- a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis
- How many people
- 110 participants
- Where
- 3 sitesFrance
- Study dates
- 5 Dec 2024to 5 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 6 months
- All sexes
- Child
Study population: Among children aged 6 months or younger included in the ENVIE study, the ENVIE_ancillaire study will be offered to those with RSV infection or to the control group.
Who may be able to join
- Written consent to take part in the study
- Registered with a social security scheme
- Cases:
- Children aged 6 months or under included in the ENVIE study. Treated for bronchiolitis caused by RSV
- Admitted to hospital following a visit to the paediatric A\&E department
- Control group:
Show all 18Show fewer
- Children aged 6 months or under included in the ENVIE study. Admitted to a standard ward or a Short-Stay Unit, or having attended the paediatric A\&E department
- For one of the following reasons:
- Febrile urinary tract infection, without acute ENT or respiratory symptoms
- Acute gastroenteritis, without acute ENT or respiratory symptoms
- Infant colic without fever, without ENT or acute respiratory condition
- Weight stagnation or feeding difficulties without fever, without acute ENT or respiratory symptoms
- Neonatal jaundice without fever, without acute ENT or respiratory symptoms
- Unexplained crying without fever, without acute ENT or respiratory symptoms
- Head injury, without acute ENT or respiratory symptoms
- Admitted for acute surgical conditions, without fever, without acute ENT or respiratory symptoms
- Nappy rash, without fever, without acute ENT or respiratory symptoms
- Fracture, without fever, without acute ENT or respiratory symptoms.
Who cannot join
- Refusal to participate by the legal representative
- Administration of palivizumab
- Maternal vaccination against RSV.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHI Créteil
Créteil
Mickaël SHUM
- Recruiting
CHU Necker
Paris
Julie TOUBIANA, PhD
- Recruiting
CHU Robert-Debré
Paris
Naïm OULDALI, phD
About this study
Among children aged ≤ 6 months included in the ENVIE study, the ENVIE_ancillaire study will be offered to cases of RSV infection or to controls. The study involves a nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip sample (dextro type). These samples will be collected specifically for the purpose of studying immunity.
A blood sample may also be requested for children weighing ≥5 kg who are included in the ENVIE_ancillaire study. The purpose of this sample collection will be to conduct an advanced immunological study
Read the detailed description
Among children aged ≤ 6 months included in the ENVIE study, the ENVIE_ancillaire study will be offered to cases of RSV infection or to controls. The study involves a nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip sample (dextro type). This sample collection will be carried out specifically for the study of immunity. Innate immune mediators (type I, II and III IFNs) and key inflammatory molecules (IL-6, TNF-alpha, IL-10) will be quantified, and adaptive immunity will be analysed by measuring local immunoglobulin titres (IgG, A, M, subclasses and specific antibodies against the inactivated virus) from the nasopharyngeal swab and blood samples absorbed onto filter paper. A blood sample may also be offered to children weighing ≥5 kg who are included in the ENVIE_ancillaire study. The purpose of this sample collection will be to conduct an advanced immunological study (identification of the host's protein, cellular and transcriptomic response). Finally, the bacterial microbiome (16S RNA) and the soluble virome will be characterised by high-throughput sequencing.
- Conditions
- Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)
- Being tested
- a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a study of the mucosal immune signature associated with hospitalised RSV bronchiolitisBiological
Once those with parental authority have confirmed their willingness for their child to take part in the research and written consent has been obtained, the following samples may be collected:
- A nasopharyngeal swab
- A 'dextro' blood sample with a blot on filter paper. The nasopharyngeal samples and blotting papers will be stored at -20°C (or -80°C if possible) and transported to the Pasteur Institute as soon as possible (just-in-time). il sera possible de proposer un prélèvement supplémentaire dans le cadre d'une étude immunologique avancée, chez les nourrissons ≥ 5 kg. Ce prélèvement comprend :
- Un tube hépariné pour plasmatèque et cellulotèque : 5 mL
- Un tube PAX gene pediatrique pour RNAtèque : 0,5 mL
| Study group | Role | What they receive |
|---|---|---|
| Case | Children aged 6 months or under included in the ENVIE study, treated for bronchiolitis caused by RSV Receives: Biological: a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis | |
| Control group | Children aged 6 months or under included in the ENVIE study, admitted to a standard ward or a Short-Stay Unit, or who have attended the paediatric A\&E department
For one of the following reasons:
* Febrile urinary tract infection, without acute ENT or respiratory symptoms
* Acute gastroenteritis, without acute ENT or respiratory symptoms
* Infant colic without fever, without ENT or
* Weight stagnation or feeding difficulties without fever, without acute ENT or respiratory symptoms
* Neonatal jaundice without fever, without acute ENT or respiratory symptoms
* Unexplained crying without fever, without acute ENT or respiratory symptoms
* Head injury, without acute ENT or respiratory symptoms
* Treated for an acute surgical condition, without fever, without acute ENT or respiratory symptoms
* Nappy rash, without fever, without acute ENT or respiratory symptoms,
* Fracture, without fever, without acute ENT or respiratory symptoms. Receives: Biological: a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start5 Dec 2024
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)Studies 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
- 110 participants (estimated)
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
- NCT07698769
- Sponsor's protocol ID
- 2024-A01208-39
- Acronym
- ENVIEANCILLAIR
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment
- ClinicalTrials.gov ID
- NCT07698769
- Acronym / sponsor ID
- ENVIEANCILLAIR / 2024-A01208-39
- Conditions
- Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 13 Jul 2026 (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.
Among children aged ≤ 6 months included in the ENVIE study, the ENVIE_ancillaire study will be offered to cases of RSV infection or to controls. The study involves a nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip sample (dextro type). These samples will be collected specifically for the purpose of studying immunity.
A blood sample may also be requested for children weighing ≥5 kg who are included in the ENVIE_ancillaire study. The purpose of this sample collection will be to conduct an advanced immunological study
Detailed description
Among children aged ≤ 6 months included in the ENVIE study, the ENVIE_ancillaire study will be offered to cases of RSV infection or to controls. The study involves a nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip sample (dextro type). This sample collection will be carried out specifically for the study of immunity. Innate immune mediators (type I, II and III IFNs) and key inflammatory molecules (IL-6, TNF-alpha, IL-10) will be quantified, and adaptive immunity will be analysed by measuring local immunoglobulin titres (IgG, A, M, subclasses and specific antibodies against the inactivated virus) from the nasopharyngeal swab and blood samples absorbed onto filter paper. A blood sample may also be offered to children weighing ≥5 kg who are included in the ENVIE_ancillaire study. The purpose of this sample collection will be to conduct an advanced immunological study (identification of the host's protein, cellular and transcriptomic response). Finally, the bacterial microbiome (16S RNA) and the soluble virome will be characterised by high-throughput sequencing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Biological: a study of the mucosal immune signature associated with hospitalised RSV bronchiolitisChildren aged 6 months or under included in the ENVIE study, treated for bronchiolitis caused by RSV |
| Control group | – | Biological: a study of the mucosal immune signature associated with hospitalised RSV bronchiolitisChildren aged 6 months or under included in the ENVIE study, admitted to a standard ward or a Short-Stay Unit, or who have attended the paediatric A\&E department For one of the following reasons: * Febrile urinary tract infection, without acute ENT or respiratory symptoms * Acute gastroenteritis, without acute ENT or respiratory symptoms * Infant colic without fever, without ENT or * Weight stagnation or feeding difficulties without fever, without acute ENT or respiratory symptoms * Neonatal jaundice without fever, without acute ENT or respiratory symptoms * Unexplained crying without fever, without acute ENT or respiratory symptoms * Head injury, without acute ENT or respiratory symptoms * Treated for an acute surgical condition, without fever, without acute ENT or respiratory symptoms * Nappy rash, without fever, without acute ENT or respiratory symptoms, * Fracture, without fever, without acute ENT or respiratory symptoms. |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Age groups
- Child
- Study population
- Among children aged 6 months or younger included in the ENVIE study, the ENVIE_ancillaire study will be offered to those with RSV infection or to the control group.
Key inclusion criteria (18 listed)
- Written consent to take part in the study
- Registered with a social security scheme
- Children aged 6 months or under included in the ENVIE study. Treated for bronchiolitis caused by RSV
- Admitted to hospital following a visit to the paediatric A\&E department
- Children aged 6 months or under included in the ENVIE study. Admitted to a standard ward or a Short-Stay Unit, or having attended the paediatric A\&E department
Key exclusion criteria (3 listed)
- Refusal to participate by the 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 |
|---|---|---|
| a study of the mucosal immune signature associated with hospitalised RSV bronchiolitisOnce those with parental authority have confirmed their willingness for their child to take part in the research and written consent has been obtained, the following samples may be collected: * A nasopharyngeal swab * A 'dextro' blood sample with a blot on filter paper. The nasopharyngeal samples and blotting papers will be stored at -20°C (or -80°C if possible) and transported to the Pasteur Institute as soon as possible (just-in-time). il sera possible de proposer un prélèvement supplémentaire dans le cadre d'une étude immunologique avancée, chez les nourrissons ≥ 5 kg. Ce prélèvement comprend : * Un tube hépariné pour plasmatèque et cellulotèque : 5 mL * Un tube PAX gene pediatrique pour RNAtèque : 0,5 mL | Biological | Case, Control group |
Primary outcome
Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines), run by Centre Hospitalier Intercommunal Creteil at 3 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 18 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie TOUBIANA, PhD (01 44 49 57 44, julie.toubiana@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines) (time frame: Baseline). 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 13 Jul 2026.