Nasopharyngeal Carriage of S. Pneumoniae

Study Overview
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Brief Summary
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This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a shift in the distribution of Streptococcus pneumoniae serotypes in children with acute otitis media and modified the resistance of this bacterial species to antibiotics.

Detailed Description
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Since September 2001, 121 pediatricians who are part of a research and teaching network (ACTIV) throughout France participated at this prospective study. From October to June of each subsequent year, children of both sexes suffering from suppurative acute otitis media (AOM) with fever and/or otalgia (in order to increase the probability of pneumococcal AOM), aged 6 to 24 months, were enrolled. And a second group of healthy children aged 6 months to 15 years were also enrolled for the main study. For ancillary study a subgroup of children were enrolled for assessment of E. coli (ESBL) resistance.

Official Title
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Observatory of Nasopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis and in Healthy Child - Ancillary Study for Detection of E Coli ESBL Carriers

Conditions
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Nasopharyngeal Carriage, Children, Only, Antibiotic Resistant Strain

Intervention / Treatment
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* Other: nasopharyngeal sample
* Other: Stools collection or anorectal swab samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: both sexes suffering from suppurative AOM age: 6 months to 24 months for AOM age: 6 months to 15 years for healthy children informed consent from parents or guardians Exclusion Criteria: Children with antibiotic treatment within 7 days before enrolment, severe underlying disease, inclusion in the study during the previous 12 months

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: multicenter nationwide prospective cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: prospective cohort<br>Nasopharyngeal sample for each enrolled children | Other: nasopharyngeal sample<br>* Nasopharyngeal swabs from children with acute otitis media aged 6 to 24 months. The swabs were analyzed by the French National Reference Centre for Pneumococci.<br>|
| Other: ESBL cohort<br>Stool or anorectal swab samples for a subgroup of children | Other: nasopharyngeal sample<br>* Nasopharyngeal swabs from children with acute otitis media aged 6 to 24 months. The swabs were analyzed by the French National Reference Centre for Pneumococci.<br>Other: Stools collection or anorectal swab samples<br>* For a subgroup of children stools samples or anorectal swab samples were collected for assessment of E. coli (ESBL) resistance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S. Pneumoniae colonisation to detect emerging serotypes | The percentage of children colonised by non vaccine serotypes - | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detect the emergence of resistance S. pneumoniae | Percentage of penicillin resistant S. pneumoniae | at inclusion | 
| Evaluation of the rhinopharyngeal carriage of other bacteria | Haemophilus influenzae, Moraxella Catarrhalis, and Staphylococcus aureus in AOM group and healthy children. | at inclusion | 
| Detect the emergence of new serotypes | > 10 Percent of isolated Sp, 5 percent of carrier children | at inclusion | 
| For the ancillary study, the resistance of E. coli (ESBL) will be evaluated. | Assessment of E. coli (ESBL) resistance. | at inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal conjugate vaccine, Streptococcus pneumoniae, Carriage