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Observatory of Streptococcus Pneumoniae Nasopharyngeal Carriage in Infants With Acute Otitis Media (AOM) and in Healthy Children

Status: Recruiting

Location: See location...

Intervention Type: Other

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 6 months

Maximum Age: 15

Healthy Volunteers: t

View:

• 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,

Locations

Other Locations

France

ACTIV

RECRUITING

Créteil

Contact Information

Primary

Corinne Levy, MD

corinne.levy@activ-france.fr

0033148850404

Backup

Stéphane Béchet, MsC

stephane.bechet@activ-france.fr

0033148850404

Time Frame

Start Date: 2001-09-11

Estimated Completion Date: 2026-12-31

Participants

Target number of participants: 25760

Treatments

Other: prospective cohort: Main study

700 children aged 6 to 36 months with AOM and 500 healthy control children aged 6 months to 15 years will be enrolled. A mandatory nasopharyngeal swab is planned for these groups.

Other: ESBL cohort- Ancillary study

For a subgroup of approximately 500 children with AOM, aged 6 to 24 months, optional stool or anorectal swab samples will be collected.

Other: Optional Nasopharyngeal sample

For a subgroup of 560 children with AOM, an optional nasal sample will be collected to assess the association of various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B) with different pneumococcal serotypes.

Related Therapeutic Areas

Flu

Otitis

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