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Clinical Trial 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.


Clinical Trial 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. 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 children were enrolled for assessment of E. coli (ESBL) resistance. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04460313
Study type Interventional
Source Association Clinique Thérapeutique Infantile du val de Marne
Contact Corinne Levy, MD
Phone 0033148850404
Email corinne.levy@activ-france.fr
Status Recruiting
Phase N/A
Start date September 11, 2001
Completion date December 1, 2024

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