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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06722716
Acronym
Synergy
Enrollment
120
Registered
2024-12-09
Start date
2025-10-31
Completion date
2026-02-28
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

Bronchiolitis, pneumonia

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.

Interventions

Nasopharyngeal swab

Sponsors

National Pneumococcal Reference Center
CollaboratorUNKNOWN
Infectious Diseases Models for Innovative Therapies
CollaboratorUNKNOWN
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp)InclusionComparison of nasopharyngeal carriage rates of Streptococcus pneumoniae (Sp) in healthy infants and infants with RSV bronchiolitis.

Secondary

MeasureTime frameDescription
Serotype profile distributionInclusionSerotypic Profile (Distribution of Serotypes) of S. pneumoniae in Nirsevimab-treated versus non-treated infants under 12 months of age, as assessed by nasopharyngeal swabs.
serotype profileInclusionComparison of the predominant serotype between the two groups.
proportion of 13-valent and 23-valent vaccine serotypesInclusionthe proportion of 13-valent and 23-valent vaccine serotypes among pneumococcal strains between the two groups
proportion of non-vaccine serotypesInclusionproportion of non-vaccine serotypes among all pneumococcal strains between the two groups

Countries

France

Contacts

Primary ContactEtienne BIZOT
etienne.bizot@aphp.fr33145374618

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026