Overview
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, 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.
Eligibility
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.
