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Nasopharyngeal Carriage of S. Pneumoniae

RecruitingNAAges 6 Months - 15 YearsAllAssociation Clinique Thérapeutique Infantile du v…
NCT04460313 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
children seen on an outpatient Inclusion Criteria: * both sexes * suffering from suppurative AOM or healthy children * age: 6 months to 36 months for AOM * age: 6 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.
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What it tests

  • nasopharyngeal sample (mandatory)
  • Stools collection or anorectal swab samples (optional)
  • nasopharyngeal sample (optional)
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Where

1 site
ACTIV
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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