BronchiolitisSynergyNCT06722716
Study of Pneumococcal Carriage in RSV Bronchiolitis in Infants Aged 6 to 18 Months
An observational study of Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Swab collection
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2025to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Chronic respiratory illness
- Medical history of bronchiolitis or newborn asthma
- Treatment with immunosuppressants
- Patient on AME
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Antoine Béclère
Clamart, 92140
Etienne BIZOT, 33145374618, etienne.bizot@aphp.fr
About this study
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).
Read the 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.
- Conditions
- Bronchiolitis
- Being tested
- Swab collection
- Keywords
- Bronchiolitis, pneumonia
- Medical subject headings
- Bronchiolitis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swab collectionOther
Nasopharyngeal swab
| Study group | Role | What they receive |
|---|---|---|
| bronchiolitis group | Nasopharyngeal swab Receives: Other: Swab collection | |
| healthy group | Infants without RSV bronchiolitis Receives: Other: Swab collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp)
Comparison of nasopharyngeal carriage rates of Streptococcus pneumoniae (Sp) in healthy infants and infants with RSV bronchiolitis.
Measured: Inclusion
Secondary outcomes (5)
serotype profile
Comparison of the predominant serotype between the two groups.
Measured: Inclusion
serotype profile
Comparison of the distribution of each serotype between the two groups.
Measured: Inclusion
proportion of 13-valent and 23-valent vaccine serotypes
the proportion of 13-valent and 23-valent vaccine serotypes among pneumococcal strains between the two groups
Measured: Inclusion
proportion of non-vaccine serotypes
proportion of non-vaccine serotypes among all pneumococcal strains between the two groups
Measured: Inclusion
Serotype profile distribution
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.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study startOct 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Pneumococcal Reference Center, Infectious Diseases Models for Innovative Therapies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722716
- Sponsor's protocol ID
- APHP240862
- Other IDs
- 2024-A01592-45
- Acronym
- Synergy
- Status last verified
- Aug 2024
- First submitted
- 25 Sep 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pneumococcal Carriage in RSV Bronchiolitis in Infants Aged 6 to 18 Months
- ClinicalTrials.gov ID
- NCT06722716
- Acronym / sponsor ID
- Synergy / APHP240862
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Pneumococcal Reference Center, Infectious Diseases Models for Innovative Therapies
- Study start
- Oct 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bronchiolitis group | – | Other: Swab collectionNasopharyngeal swab |
| healthy group | – | Other: Swab collectionInfants without RSV bronchiolitis |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Chronic respiratory illness
- Medical history of bronchiolitis or newborn asthma
- Treatment with immunosuppressants
- Patient on AME
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swab collectionNasopharyngeal swab | Other | bronchiolitis group, healthy group |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Etienne BIZOT (33145374618, etienne.bizot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp) (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.