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Nasopharyngeal Carriage of S. Pneumoniae

NCT04460313 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25760

Last updated 2026-03-19

No results posted yet for this 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.

Conditions

  • Nasopharyngeal Carriage
  • Children, Only
  • Antibiotic Resistant Strain

Interventions

OTHER

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.

OTHER

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

OTHER

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Association Clinique Thérapeutique Infantile du val de Marne

    lead OTHER

Principal Investigators

  • Robert Cohen, MD · Association Clinique Thérapeutique Infantile du val de Marne

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-09-11
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460313 on ClinicalTrials.gov