[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397837":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":28,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":28,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":53,"whyStopped":28,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Association Clinique Thérapeutique Infantile du val de Marne","OTHER",[8,13,19],{"label":9,"type":6,"description":10,"interventionNames":11},"prospective cohort: Main study","700 children aged 6 to 36 months with AOM and 500 healthy control children aged 6 months to 15 years will be enrolled. A mandatory nasopharyngeal swab is planned for these groups.",[12],"Other: nasopharyngeal sample (mandatory)",{"label":14,"type":6,"description":15,"interventionNames":16},"ESBL cohort- Ancillary study","For a subgroup of approximately 500 children with AOM, aged 6 to 24 months, optional stool or anorectal swab samples will be collected.",[12,17,18],"Other: Stools collection or anorectal swab samples (optional)","Other: nasopharyngeal sample (optional)",{"label":20,"type":6,"description":21,"interventionNames":22},"Optional Nasopharyngeal sample","For a subgroup of 560 children with AOM, an optional nasal sample will be collected to assess the association of various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B) with different pneumococcal serotypes.",[12,18],[24,29,33],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"nasopharyngeal sample (mandatory)","A mandatory nasopharyngeal swab is planned for each included patient: patients aged 6 to 36 months with AOM and control children (healthy) aged 6 months to 15 years. The bacteriological analyses will be carried out by the French National Reference Centre for Pneumococci.",[14,20,9],null,{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Stools collection or anorectal swab samples (optional)","For a subgroup of AOM children aged 6 to 36 months, stools samples or anorectal swab samples were collected for assessment of E. coli (ESBL) resistance",[14],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"nasopharyngeal sample (optional)","Optional nasopharyngeal swabs from children with AOM aged 6 to 36 months to assess the association of various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B) with different pneumococcal serotypes.",[14,20],[38],{"name":39,"affiliation":5,"role":40},"Robert Cohen, MD","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Corinne Levy, MD","CONTACT","0033148850404","corinne.levy@activ-france.fr",{"name":48,"role":44,"phone":45,"phoneExt":28,"email":49},"Stéphane Béchet, MsC","stephane.bechet@activ-france.fr",[51],{"facility":52,"status":53,"city":54,"state":28,"zip":28,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"ACTIV","RECRUITING","Créteil","France","FR",{"type":58,"coordinates":59},"Point",[60,61],2.46569,48.79266,{"lat":61,"lon":60},[64,65],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"name":66,"role":44,"phone":45,"phoneExt":28,"email":49},"Stéphane Béchet, MSc",{"type":68,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[70],{"name":71,"class":72},"Pfizer","INDUSTRY","100397837","nasopharyngeal-carriage-of-s-pneumoniae-100397837",false,"NCT04460313","Nasopharyngeal Carriage of S. Pneumoniae","Observatory of Streptococcus Pneumoniae Nasopharyngeal Carriage in Infants With Acute Otitis Media (AOM) and in Healthy Children\"","children seen on an outpatient\n\nInclusion Criteria:\n\n* both sexes\n* suffering from suppurative AOM or healthy children\n\n  * age: 6 months to 36 months for AOM\n  * age: 6 months to 15 years for healthy children\n* informed consent from parents or guardians\n* Children who haven't received antibiotic treatment within 7 days before enrollment,\n\nExclusion Criteria:\n\n* severe underlying disease,\n* inclusion in the study during the previous 12 months\n* Children with bullous myringitis cannot be included.",true,"ALL","6 Months","15 Years",{"count":85,"type":86},25760,"ESTIMATED","INTERVENTIONAL",[89],"NA","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.",[92,93,94],"Nasopharyngeal Carriage","Children, Only","Antibiotic Resistant Strain",[96,97,98],"Pneumococcal conjugate vaccine","Streptococcus pneumoniae","Carriage","2026-03-17",{"date":101,"type":102},"2026-03-19","ACTUAL",{"date":104,"type":102},"2001-09-11",{"date":106,"type":86},"2026-12-31",{"name":5,"class":6},1]