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

NCT ID: NCT06722716

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Bronchiolitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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bronchiolitis group

Nasopharyngeal swab

Swab collection

Intervention Type OTHER

Nasopharyngeal swab

healthy group

Infants without RSV bronchiolitis

Swab collection

Intervention Type OTHER

Nasopharyngeal swab

Interventions

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Swab collection

Nasopharyngeal swab

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Pneumococcal Reference Center

UNKNOWN

Sponsor Role collaborator

Infectious Diseases Models for Innovative Therapies

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Antoine Béclère

Clamart, , France

Site Status

Countries

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France

Central Contacts

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Etienne BIZOT

Role: CONTACT

33145374618

Facility Contacts

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Etienne BIZOT

Role: primary

33145374618

Other Identifiers

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2024-A01592-45

Identifier Type: OTHER

Identifier Source: secondary_id

APHP240862

Identifier Type: -

Identifier Source: org_study_id

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