Nasopharyngeal Carriage of S. Pneumoniae
Observatory of Streptococcus Pneumoniae Nasopharyngeal Carriage in Infants With Acute Otitis Media (AOM) and in Healthy Children"
Association Clinique Thérapeutique Infantile du val de Marne
25,760 participants
Sep 11, 2001
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- children seen on an outpatient
- 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 Criteria3
- severe underlying disease,
- inclusion in the study during the previous 12 months
- Children with bullous myringitis cannot be included.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04460313