Study of Pneumococcal Carriage in RSV Bronchiolitis in Infants Aged 6 to 18 Months
Synergy
2 other identifiers
observational
120
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2024
CompletedFirst Posted
Study publicly available on registry
December 9, 2024
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedMay 15, 2025
August 1, 2024
4 months
September 25, 2024
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp)
Comparison of nasopharyngeal carriage rates of Streptococcus pneumoniae (Sp) in healthy infants and infants with RSV bronchiolitis.
Inclusion
Secondary Outcomes (5)
serotype profile
Inclusion
serotype profile
Inclusion
proportion of 13-valent and 23-valent vaccine serotypes
Inclusion
proportion of non-vaccine serotypes
Inclusion
Serotype profile distribution
Inclusion
Study Arms (2)
bronchiolitis group
Nasopharyngeal swab
healthy group
Infants without RSV bronchiolitis
Interventions
Eligibility Criteria
The included population will consist of infants aged 6 to 18 months, divided into two groups. On one hand, infants with RSV bronchiolitis (regardless of severity) and on the other hand, RSV-negative infants (consulting for other reasons, such as trauma, jaundice, etc.). The recruitment age is justified by the peak occurrence of invasive pneumococcal infections, which typically occurs around 12 months of age.
You may qualify if:
- 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
You may not qualify if:
- Chronic respiratory illness
- Medical history of bronchiolitis or newborn asthma
- Treatment with immunosuppressants
- Patient on AME
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Antoine Béclère
Clamart, 92140, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2024
First Posted
December 9, 2024
Study Start
October 1, 2025
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
May 15, 2025
Record last verified: 2024-08