Study of Pneumococcal Carriage in RSV Bronchiolitis in Infants Aged 6 to 18 Months
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Swab collection.
- Who it may be relevant to
- Registry conditions: Bronchiolitis. Basic parameters: 6 months — 18 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Swab collection
Nasopharyngeal swab
Primary outcome measures
- nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp) [Time frame: Inclusion]
Secondary outcome measures (5)
- serotype profile [Time frame: Inclusion]
- serotype profile [Time frame: Inclusion]
- proportion of 13-valent and 23-valent vaccine serotypes [Time frame: Inclusion]
- proportion of non-vaccine serotypes [Time frame: Inclusion]
- Serotype profile distribution [Time frame: Inclusion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Hôpital Antoine Béclère — Clamart
Identifiers
NCT: NCT06722716 · APHP240862 · 2024-A01592-45