Evaluation of the Effect of Nirsevimab on Hospitalization... | NCT06856967

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

NCT06856967

Sponsor

Meyer Children's Hospital IRCCS

Status

Recruiting

Last Update Posted

Mar 10, 2025Actual

Enrollment

138Estimated

Phase

Not provided

Conditions

Respiratory Synctial Virus Infections

Interventions

Nirsevimab

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2024Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Apr 2025Estimated

First Submitted Date

Feb 26, 2025

First Submission Date that Met QC Criteria

Feb 26, 2025

First Posted Date

Mar 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2025

Last Update Posted Date

Mar 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

138Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nirsevimab	Drug	Evaluation of drug exposure in cases and controls	Cases Controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.		November 2024-March 2025

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Months

Standard Ages

Child

Study Population

Infants < 12 months during RSV 2024-2025 epidemic season

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giuseppe Indolfi	Contact	+3905556621		giuseppe.indolfi@meyer.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SOC Pediatria Ospedale San Donato	Recruiting	Arezzo	Arezzo	52100	Italy

Intervention Browse Module

MeSH Terms

ID	Term
C000709769	nirsevimab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided