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NCT04460313
Nasopharyngeal Carriage of S. Pneumoniae
Conditions: Nasopharyngeal Carriage, Children, Only, Antibiotic Resistant Strain
Sex: All
Ages: 4 Months – 15 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 29360
Sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Location: ACTIV Créteil
Summary
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.
Eligibility Criteria
children seen on an outpatient
Inclusion Criteria:
* both sexes
* suffering from suppurative AOM or healthy children
* age: 4 months to 36 months for AOM
* age: 4 months to 15 years for healthy children
* informed consent from parents or guardians
* Children who haven't received antibiotic treatment within 7 days before enrollment,
Exclusion Criteria:
* severe underlying disease,
* inclusion in the study during the previous 12 months
* Children with bullous myringitis cannot be included.
Source: ClinicalTrials.gov (NCT04460313). StuddyBuddy aggregates publicly available trial information.