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Nasopharyngeal Carriage of S. Pneumoniae
Sponsor: Association Clinique Thérapeutique Infantile du val de Marne
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.
Official title: Observatory of Streptococcus Pneumoniae Nasopharyngeal Carriage in Infants With Acute Otitis Media (AOM) and in Healthy Children"
Key Details
Gender
All
Age Range
6 Months - 15 Years
Study Type
INTERVENTIONAL
Enrollment
25760
Start Date
2001-09-11
Completion Date
2026-12-31
Last Updated
2026-03-19
Healthy Volunteers
Yes
Interventions
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.
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
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.
Locations (1)
ACTIV
Créteil, France