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Immune clues in severe RSV: what makes some babies sicker?

NCT ID NCT07698769

Knowledge-focused Sponsor: Centre Hospitalier Intercommunal Creteil Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study looks at the immune system's response in infants aged 6 months or younger who are hospitalized with RSV bronchiolitis. Researchers will collect nasal swabs and blood samples to measure immune markers like interferons and cytokines. The goal is to understand why some babies develop severe illness, which could inform future prevention or treatment strategies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify immune markers that predict severe RSV, guiding future treatments or vaccines.
What could go wrong
This is an observational study with a small sample size (110 infants), so findings may not apply to all children or lead directly to new therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

0 to 6 months

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 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. Exclusion Criteria: * Refusal to participate by the legal representative * Administration of palivizumab * Maternal vaccination against RSV.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus bronchiolitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHI Créteil

    RECRUITING

    Créteil, France

  • CHU Necker

    RECRUITING

    Paris, France

  • CHU Robert-Debré

    RECRUITING

    Paris, France