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

ConditionBronchiolitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Chronic respiratory illness

Medical history of bronchiolitis or newborn asthma

Treatment with immunosuppressants

Patient on AME

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Swab collection

    Other intervention

    Nasopharyngeal swab

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: bronchiolitis group1 intervention
Group B: healthy group1 intervention

Trial outcomes

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.

Time frame
Inclusion

Secondary outcomes

1

serotype profile

Comparison of the predominant serotype between the two groups.

Time frame
Inclusion
2

serotype profile

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

Time frame
Inclusion
3

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

Time frame
Inclusion
4

proportion of non-vaccine serotypes

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

Time frame
Inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

National Pneumococcal Reference Center

Collaborator

Infectious Diseases Models for Innovative Therapies

Collaborator

This trial is not recruiting at the moment. You can still explore other options: