Antibiotic Resistant Strain, Children, Only, Nasopharyngeal Carriage
Conditions
Keywords
Pneumococcal conjugate vaccine, Streptococcus pneumoniae, Carriage
Brief 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.
Detailed 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.
Interventions
OTHERnasopharyngeal 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.
OTHERStools 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
OTHERnasopharyngeal 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.
Sponsors
Association Clinique Thérapeutique Infantile du val de Marne
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
multicenter nationwide prospective cohort
Eligibility
Sex/Gender
ALL
Age
6 Months to 15 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detect the emergence of new serotypes | at inclusion | Percentage of emerging serotypes detected (\> 10 Percent of isolated Sp, 5 percent of carrier children) |
| 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 |
| S. Pneumoniae colonisation | at inclusion | Percentage of children colonised by S. Pneumoniae |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detect the emergence of resistance S. pneumoniae | at inclusion | Percentage of penicillin resistant S. pneumoniae |
| Evaluation of nasopharyngeal carriage of other bacteria | at inclusion | Assessment of carriage of Haemophilus influenzae, Moraxella Catarrhalis, Staphylococcus aureus and group A Streptococcus in AOM group and in healthy children group. |
| For the ancillary study, the resistance of E. coli (ESBL) will be evaluated. | at inclusion | Assessment of E. coli (ESBL) resistance. |
Countries
France
Contacts
CONTACTCorinne Levy, MD
CONTACTStéphane Béchet, MsC
PRINCIPAL_INVESTIGATORRobert Cohen, MD
Association Clinique Thérapeutique Infantile du val de Marne
Outcome results
None listed