[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397837":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":66,"collaborators":68,"id":72,"slug":28,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":28,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":28,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":53,"whyStopped":28,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"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,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"ACTIV","RECRUITING","Créteil","France",{"type":57,"coordinates":58},"Point",[59,60],2.46569,48.79266,{"lat":60,"lon":59},[63,64],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"name":65,"role":44,"phone":45,"phoneExt":28,"email":49},"Stéphane Béchet, MSc",{"type":67,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[69],{"name":70,"class":71},"Pfizer","INDUSTRY","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":83,"type":84},25760,"ESTIMATED","INTERVENTIONAL",[87],"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.",[90,91,92],"Nasopharyngeal Carriage","Children, Only","Antibiotic Resistant Strain",[94,95,96],"Pneumococcal conjugate vaccine","Streptococcus pneumoniae","Carriage","2026-03-17",{"date":99,"type":100},"2026-03-19","ACTUAL",{"date":102,"type":100},"2001-09-11",{"date":104,"type":84},"2026-12-31",{"name":5,"class":6},1]