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RecruitingNCT06856967Updated Mar 10, 2025

Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.

An observational study in Respiratory Synctial Virus Infections, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 8 sites in Italy. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Meyer Children's Hospital IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
138
Ages
Up to 12 Months
Sex
All
01

Study summary

This study aims to evaluate the impact of Nirsevimab, a monoclonal antibody used for RSV prophylaxis, on reducing RSV- related hospitalizations. It will be conducted at 8 pediatric departments in Tuscany, Italy. First, a matched case-control study investigates the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations during the RSV epidemic season 2024-2025. Second, a descriptive study examines how the Nirsevimab immunization campaign affects RSV epidemiology, focusing on patients' age, comorbidities, infection severity, and clinical outcomes. The findings aim to optimize RSV prevention strategies and inform public health policies.

02

Conditions studied

  • Respiratory Synctial Virus Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 138 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infants \< 12 months during RSV 2024-2025 epidemic season

Inclusion criteria

Case patients

  • Age \<12 months
  • Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
  • Positive RSV PCR on nasopharyngeal swab Control patients
  • Age \<12 months
  • Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
  • Hospitalized for conditions other than respiratory infections

Exclusion criteria

Exclusion Criteria:

  • Parental refusal
  • Previous immunization with Palivizumab
  • Previous maternal RSV vaccine immunization during pregnancy
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
138 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cases

    Patients aged \<1 years hospitalized with confirmed bronchiolitis

    Drug: Nirsevimab

  • Controls

    Patients aged \<1 years hospitalized for condition other than confirmed bronchiolitis

    Drug: Nirsevimab

Interventions

  • DrugNirsevimab

    Evaluation of drug exposure in cases and controls

06

What researchers measure

Primary outcomes

  1. The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.

    Time frame: November 2024-March 2025

07

Study locations

8 of 8 sites recruiting
  • SOC Pediatria Ospedale Santa Maria Annunziata
    Bagno a Ripoli, Firenze 50012, Italy
    Recruiting
  • SOC Pediatria Ospedale San Donato
    Arezzo, 52100, Italy
    Recruiting
  • SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
    Firenze, 50134, Italy
    Recruiting
  • Meyer Children's Hospital IRCCS
    Florence, 50139, Italy
    • Giuseppe Indolfi · Principal investigator
    Recruiting
  • Azienda Ospedaliero Universitaria Pisana
    Pisa, 56123, Italy
    • Diego Peroni · Principal investigator
    Recruiting
  • SOC Pediatria e Neonatologia Ospedale San Jacopo
    Pistoia, 51100, Italy
    Recruiting
  • SOC Pediatria e Neonatologia Ospedale Santo Stefano
    Prato, 59100, Italy
    Recruiting
  • SOC Pediatria AOU Senese
    Siena, 53100, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06856967
Lead sponsor
Meyer Children's Hospital IRCCS
Responsible party
Giuseppe Indolfi (MD, Meyer Children's Hospital IRCCS) — Principal investigator
First posted
Mar 4, 2025
Start date
Dec 4, 2024
Primary completion
Mar 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Mar 10, 2025

Study contacts

Giuseppe Indolfi
Contact
giuseppe.indolfi@meyer.it
+3905556621

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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