Nasopharyngeal Carriage of S. Pneumoniae

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    25000
  • sponsor
    Association Clinique Thérapeutique Infantile du val de Marne
Updated on 31 March 2021

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.

Description

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.

Details
Condition Only Child, Nasopharyngeal Carriage, Antibiotic Resistant Strain
Treatment nasopharyngeal sample
Clinical Study IdentifierNCT04460313
SponsorAssociation Clinique Thérapeutique Infantile du val de Marne
Last Modified on31 March 2021

Eligibility

Yes No Not Sure

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
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