Study of Pneumococcal Carriage in RSV Bronchiolitis in Infants Aged 6 to 18 Months (Synergy)

The relationship between RSV (human respiratory syncytial virus) infections and invasive infections or pneumonia caused by Streptococcus pneumoniae has been observed epidemiologically for several years. Few fundamental data exist to support the epidemiological relationship. This study will investigate the proportion of pneumococcal carriage in RSV-infected infants and noninfected infants (proportion, serotype profile).

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Swab collection

Detailed Description

The relationship between RSV (human respiratory syncytial virus) infections and Streptococcus pneumoniae pneumonia has been suggested for many years based on a similar seasonal pattern and cohort studies, but it could not be confirmed due to the circulation of several viruses concurrently. The post-COVID-19 period was marked by a temporal association between RSV infections and invasive pneumococcal disease (and pneumonia) in children under five, highlighting the potential role of RSV in the dynamics of pneumococcal disease in infants.

Furthermore, the carriage rate of S. pneumoniae in infants under 2 years of age in healthy populations is described as around 25%. In the case of RSV infection, this rate rises to 50%. Some data from animal models have shown that RSV infection increases S. pneumoniae transmission within a group of individuals, partly explaining this difference. However, data remain limited, particularly in human samples, and further research is needed to better understand the role of the RSV-pneumococcal relationship in the occurrence of severe RSV infections (pneumonia) and invasive pneumococcal infections. This study will examine pneumococcal carriage in bronchiolitis in infants aged 6-18 months, through nasopharyngeal swabs from infants with bronchiolitis and healthy infants. Pneumococcal carriage rates and serotype profiles will be investigated.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Etienne BIZOT; Phone Number: 33145374618; Email: etienne.bizot@aphp.fr

Study Locations

• France
  • Clamart, France, 92140
    • Hôpital Antoine Béclère
    • Contact: Etienne BIZOT; Phone Number: 33145374618; Email: etienne.bizot@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The included population will consist of infants aged 6 to 18 months, divided into two groups. On one hand, infants with RSV bronchiolitis (regardless of severity) and on the other hand, RSV-negative infants (consulting for other reasons, such as trauma, jaundice, etc.). The recruitment age is justified by the peak occurrence of invasive pneumococcal infections, which typically occurs around 12 months of age.

Description

Inclusion Criteria:

• Infants aged 6 months to 18 months inclusive
• With bronchiolitis during RSV epidemic season (bronchiolitis group) or without evidence of RSV viral infection (healthy group)
• No chronic illness
• No history of bronchiolitis
• Signed consent from parents or legal guardians
• Patient affiliated to a social security scheme

Exclusion Criteria:

• Chronic respiratory illness
• Medical history of bronchiolitis or newborn asthma
• Treatment with immunosuppressants
• Patient on AME

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
bronchiolitis group; Nasopharyngeal swab	Other: Swab collection; Nasopharyngeal swab
healthy group; Infants without RSV bronchiolitis	Other: Swab collection; Nasopharyngeal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp)	Comparison of nasopharyngeal carriage rates of Streptococcus pneumoniae (Sp) in healthy infants and infants with RSV bronchiolitis.	Inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serotype profile	Comparison of the predominant serotype between the two groups.	Inclusion
serotype profile	Comparison of the distribution of each serotype between the two groups.	Inclusion
proportion of 13-valent and 23-valent vaccine serotypes	the proportion of 13-valent and 23-valent vaccine serotypes among pneumococcal strains between the two groups	Inclusion
proportion of non-vaccine serotypes	proportion of non-vaccine serotypes among all pneumococcal strains between the two groups	Inclusion
Serotype profile distribution	Serotypic Profile (Distribution of Serotypes) of S. pneumoniae in Nirsevimab-treated versus non-treated infants under 12 months of age, as assessed by nasopharyngeal swabs.	Inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: National Pneumococcal Reference Center; Infectious Diseases Models for Innovative Therapies

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: pneumonia; Bronchiolitis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: APHP240862; 2024-A01592-45 (Other Identifier: ANSM : Agence nationale de sécurité du médicament et des produits de santé)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No