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

Not yet recruiting

• Conditions: Bronchiolitis

• Registration Number: NCT06722716
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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).

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-01
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp)	Inclusion	Comparison of nasopharyngeal carriage rates of Streptococcus pneumoniae (Sp) in healthy infants and infants with RSV bronchiolitis.

Secondary Outcome Measures

Name	Time	Method
serotype profile	Inclusion	Comparison of the distribution of each serotype between the two groups.
proportion of 13-valent and 23-valent vaccine serotypes	Inclusion	the proportion of 13-valent and 23-valent vaccine serotypes among pneumococcal strains between the two groups
proportion of non-vaccine serotypes	Inclusion	proportion of non-vaccine serotypes among all pneumococcal strains between the two groups
Serotypic Profile	Inclusion	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.

Trial Locations

Locations (1)

Hôpital Antoine Béclère; 🇫🇷 Clamart, France