Evaluation in Practice of the Impact of NIrsevimab on EmeRgency Use for BRONCHIOlitis

NCT06185647 | Completed

• 1 other identifier: 20231213191724
• Study Type: observational
• Target: 4,924
• Locations: 1 country
• Sites: 1

Brief Summary

In July 2023, the Food and Drug Administration approved nirsevimab (Beyfortus®), a long-acting monoclonal antibody, for passive immunization to prevent RSV-associated lower respiratory tract infection (Bronchiolitis) among infants and young children. In Europe, The European Medicines Agency approved the use of BEYFORTUS in October 2022. In France, The Haute Autorité de Santé (HAS) approved the use of BEYFORTUS in July 2023 starting in September 2023. Beyfortus is administered as a single intramuscular injection prior to or during RSV season. This single dose may provide protection during the whole RSV season. The safety and efficacy of Beyfortus® were supported by three clinical trials (1-3). The key measure of efficacy was the incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI ) evaluated during the 150 days after Beyfortus® administration. Beyfortus® reduced the risk of MA RSV LRTI by approximately 70% to 75% relative to placebo. The objective of this observational study is to assess in the real-world the effectiveness of nirsevimab on the Emergency Department use for bronchiolitis as well on the effectiveness of nirsevimab to reduce hospitalization and healthcare usage in France where a national campaign to administer nirsevimab to young infants stated on September 14th, 2023. Type of study Retrospective observational study of medical records which include systematic and prospective data on nirsevimab immunization status of patients visiting the Emergency Department. Methodology This retrospective observational study will include two data set analysis. On one part, data from all infants presenting to the emergency department and diagnosed as having bronchiolitis will be retrieved from medical and nursing records and those who had been given nirsevimab will be compared with those who did not receive this medication prior to the ED visit. On the other part, since the investigators have included nirsevimab administration in their systematic data collection on immunization of all infants visiting our ED, the investigators will use the nirsevimab immunization status of infants diagnosed as having bronchiolitis with those do not having bronchiolitis in order to assess the effectiveness (real-world effect) of nirsevimab on the ED use and hospitalization.

Conditions

Bronchiolitis; Respiratory Syncytial Virus (RSV); Immunization; Infection

Outcome Measures

Primary Outcomes (2)

• Real-world effectiveness of nirsevimab to reduce emergency use for bronchiolitis

  Determination of the nirsevimab effectiveness by using the screening method and the negative-test design

  Bronchiolitis season: Octobre 2023-February 2024

• Hospital resources usage of bronchiolitis patients with and without previous administration of nirsevimab

  Infants presenting bronchiolitis and having received nirsevimab will be compared to those who did not receive this medication.

  Bronchiolitis season: Octobre 2023-February 2024

Secondary Outcomes (1)

• Age distribution of bronchiolitis patients visiting the ermergency department during the 2023-2024, 2022-2023 and 2019-2020 seasons

  Bronchiolitis season: Octobre 2023-February 2024

Study Arms (2)

All infants visiting the Emergency department from october 2023 to february 2024

Extraction from medical and nursing records data on the previous administration of nirsevimab and determin whether a bronchiolitis diagnosis was given in the pediatric emergency department This information was inserted systematically in the PED records on October 31st, 2023

All infants having the diagnosis of bronchiolitis

All patients visiting the PED for bronchiolitis. Comparison of those who received previously nirsevimab and those who did not.

Other: No intervention. Observational retrospective study

Interventions

No intervention. Observational retrospective study OTHER

No intervention.

All infants having the diagnosis of bronchiolitis

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective observational study will include two data set analysis. On one part, data from all infants presenting to the emergency department and diagnosed as having bronchiolitis will be retrieved from medical and nursing records and those who had been given nirsevimab will be compared with those who did not receive this medication prior to the ED visit. On the other part, since we have included nirsevimab administration in our systematic data collection on immunization of all infants visiting our ED, we will use the nirsevimab immunization status of infants diagnosed as having bronchiolitis with those do not having bronchiolitis in order to assess the effectiveness (real-world effect) of nirsevimab on the ED use and hospitalization

You may qualify if:

• All infants aged 1 year or youger visiting the emergecy department
• All bronchiolitis visiting the emergency department during the 2023-2024 season

You may not qualify if:

• None

Sponsors & Collaborators

• Hôpital Armand Trousseau: lead

Study Sites (1)

Hôpital Armand Trousseau

Paris, 75012, France

Location

Related Publications (3)

• Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.

  PMID: 35235726 BACKGROUND

• Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simoes EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556.

  PMID: 32726528 BACKGROUND

• Domachowske J, Madhi SA, Simoes EAF, Atanasova V, Cabanas F, Furuno K, Garcia-Garcia ML, Grantina I, Nguyen KA, Brooks D, Chang Y, Leach A, Takas T, Yuan Y, Griffin MP, Mankad VS, Villafana T; MEDLEY Study Group. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022 Mar 3;386(9):892-894. doi: 10.1056/NEJMc2112186. No abstract available.

  PMID: 35235733 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis; Infections

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: October 14, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)