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Clinical Trials in France / NCT07893652
Starting soon Observational

Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis

NCT07893652 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2026-11-15
Last updated
2026-10-26

Condition(s) studied

Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection

Investigational drug(s) / intervention(s)

Prior exposure to prophylactic treatment with Abrysvo or nirsevimab/clesrovimabNon-exposure to prior prophylactic treatment

Prior exposure to prophylactic treatment with Abrysvo or nirsevimab/clesrovimab: Being born to a woman having received Abrysvo vaccine ≥ 14 days before delivery (thus, children born to mothers vaccinated \<14 days before delivery will be considered as "unexposed" to Abrysvo) AND being less than 12 months of age at the time of admission for RSV LRTI OR having received nirsevimab or clesrovimab ≥ 7 days and \< 12 months before admission for RSV LRTI (thus, children admitted \< 7 days after nirsevimab/clesrovimab administration will be considered as "unexposed" to nirsevimab/clesrovimab).

Non-exposure to prior prophylactic treatment: all other children will be considered as non-exposed to prophylaxis

Study summary

Hospitalization for RSV lower respiratory tract infections (LRTI) still occurs, including in infants having received nirsevimab/clesrovimab or born to mothers vaccinated with Abrysvo.

We hypothesize that pediatric patients hospitalized for RSV LRTIs occurring in the era of large use of prophylaxis, could be, at least in part, explained by virological factors (emergence/selection of variants with decreased susceptibility to prophylaxis) and/or immunological factors (inherited immune deficiency, presence of auto-antibodies neutralizing anti-viral cytokines such as type I interferons, impaired mucosal responses or mucosal pharmacokinetics issues inducing low levels of local concentrations of nirsevimab/clesrovimab).

Eligibility

Sex
ALL
Min age
—
Max age
24 Months
Healthy volunteers
No
Inclusion Criteria: * Child \< 24 months * Admission to the hospital for RSV-related lower respiratory tract infections (LRTI), on the basis of the treating physician's decision and a confirmation of RSV by means of a positive result of a test performed in accordance with routine clinical practice * Informed consent of legal representative(s) of the child Exclusion Criteria: * Prior exposure to other RSV prophylaxis than maternal Abrysvo vaccine or nirsevimab/clesrovimab * Admission not directly related to RSV-related LRTI, according to the investigator's judgment * Nosocomial RSV-associated LRTI (defined by respiratory symptoms attributed to RSV occurring \>7 days after admission for another cause) * No healthcare insurance

Primary outcome measure(s)

  • RSV variants with reduced sensitivity to prophylaxis — Day0/At inclusion
    Detection of virological variants with decreased sensitivity to the prophylaxis previously administered (nirsevimab/clesrovimab and/or Abrysvo), performed by sequencing the full-length RSV genome to detect any polymorphisms and/or resistance associated mutations in the F protein

Trial sites (1)

FacilityCityRegionStatus
Hôpital Necker - Enfants Malades Paris France

More Assistance Publique - Hôpitaux de Paris trials in France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07893652 on ClinicalTrials.gov ↗ ← All trials in France