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NCT Number: NCT06722716

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

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).

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Key information

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swab collection

Other

Nasopharyngeal swab

Primary outcomes

  1. nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp)

    Time frame: Inclusion

    Comparison of nasopharyngeal carriage rates of Streptococcus pneumoniae (Sp) in healthy infants and infants with RSV bronchiolitis.

Secondary outcomes

  1. serotype profile

    Time frame: Inclusion

    Comparison of the predominant serotype between the two groups.

  2. serotype profile

    Time frame: Inclusion

    Comparison of the distribution of each serotype between the two groups.

  3. proportion of 13-valent and 23-valent vaccine serotypes

    Time frame: Inclusion

    the proportion of 13-valent and 23-valent vaccine serotypes among pneumococcal strains between the two groups

  4. proportion of non-vaccine serotypes

    Time frame: Inclusion

    proportion of non-vaccine serotypes among all pneumococcal strains between the two groups

  5. Serotype profile distribution

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Etienne BIZOT

CONTACT

[email protected]

33145374618

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Infectious Diseases Models for Innovative Therapies
  • National Pneumococcal Reference Center

Registry information

Acronym: Synergy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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