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.
Since September 2001, 54 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 36 months, were enrolled. And a second group of healthy children aged 6 months to 15 years were also enrolled for the main study. For ancillary study a subgroup of AOM children were enrolled for assessment of E. coli (ESBL) resistance.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
25,760
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.
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
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.
ACTIV
Créteil, France
RECRUITINGS. Pneumoniae colonisation
Percentage of children colonised by S. Pneumoniae
Time frame: at inclusion
S. Pneumoniae colonisation involving to vaccine serotypes
Percentage of children colonised by vaccine serotypes
Time frame: at inclusion
S. Pneumoniae colonisation involving to non vaccine serotypes
Percentage of children colonised by non vaccine serotypes
Time frame: at inclusion
Reduced of sensitivity to penicillin
Percentage of Sp carriers with reduced sensitivity to penicillin
Time frame: at inclusion
Detect the emergence of new serotypes
Percentage of emerging serotypes detected (\> 10 Percent of isolated Sp, 5 percent of carrier children)
Time frame: at inclusion
Association of Pneumococcal Serotypes with Respiratory Viruses
Percentage of pneumococcal serotypes associated with various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B) in children with AOM.
Time frame: at inclusion
Detect the emergence of resistance S. pneumoniae
Percentage of penicillin resistant S. pneumoniae
Time frame: at inclusion
Evaluation of nasopharyngeal carriage of other bacteria
Assessment of carriage of Haemophilus influenzae, Moraxella Catarrhalis, Staphylococcus aureus and group A Streptococcus in AOM group and in healthy children group.
Time frame: at inclusion
For the ancillary study, the resistance of E. coli (ESBL) will be evaluated.
Assessment of E. coli (ESBL) resistance.
Time frame: at inclusion
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