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.
Study 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
Sex
ALL
Min age
6 Months
Max age
15 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
S. Pneumoniae colonisation — at inclusion Percentage of children colonised by S. Pneumoniae
S. Pneumoniae colonisation involving to vaccine serotypes — at inclusion Percentage of children colonised by vaccine serotypes
S. Pneumoniae colonisation involving to non vaccine serotypes — at inclusion Percentage of children colonised by non vaccine serotypes
Reduced of sensitivity to penicillin — at inclusion Percentage of Sp carriers with reduced sensitivity to penicillin
Detect the emergence of new serotypes — at inclusion Percentage of emerging serotypes detected (\> 10 Percent of isolated Sp, 5 percent of carrier children)
Association of Pneumococcal Serotypes with Respiratory Viruses — at inclusion Percentage of pneumococcal serotypes associated with various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B) in children with AOM.
Trial sites (1)
Facility
City
Region
Status
ACTIV
Créteil
France
Recruiting
More Association Clinique Thérapeutique Infantile du val de Marne trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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