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NCT Number: NCT04460313

Nasopharyngeal Carriage of S. Pneumoniae

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.

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Key information

Conditions

Nasopharyngeal Carriage Antibiotic Resistant Strain Children, Only

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasopharyngeal sample (mandatory)

Other

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)

Other

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)

Other

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.

Primary outcomes

  1. S. Pneumoniae colonisation

    Time frame: at inclusion

    Percentage of children colonised by S. Pneumoniae

  2. S. Pneumoniae colonisation involving to vaccine serotypes

    Time frame: at inclusion

    Percentage of children colonised by vaccine serotypes

  3. S. Pneumoniae colonisation involving to non vaccine serotypes

    Time frame: at inclusion

    Percentage of children colonised by non vaccine serotypes

  4. Reduced of sensitivity to penicillin

    Time frame: at inclusion

    Percentage of Sp carriers with reduced sensitivity to penicillin

  5. Detect the emergence of new serotypes

    Time frame: at inclusion

    Percentage of emerging serotypes detected (> 10 Percent of isolated Sp, 5 percent of carrier children)

  6. Association of Pneumococcal Serotypes with Respiratory Viruses

    Time frame: at inclusion

    Percentage of pneumococcal serotypes associated with various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B) in children with AOM.

Secondary outcomes

  1. Detect the emergence of resistance S. pneumoniae

    Time frame: at inclusion

    Percentage of penicillin resistant S. pneumoniae

  2. Evaluation of nasopharyngeal carriage of other bacteria

    Time frame: at inclusion

    Assessment of carriage of Haemophilus influenzae, Moraxella Catarrhalis, Staphylococcus aureus and group A Streptococcus in AOM group and in healthy children group.

  3. For the ancillary study, the resistance of E. coli (ESBL) will be evaluated.

    Time frame: at inclusion

    Assessment of E. coli (ESBL) resistance.

Study contacts

Contact information is provided by the study sponsor or research team.

Corinne Levy, MD

CONTACT

[email protected]

0033148850404

Stéphane Béchet, MsC

CONTACT

[email protected]

0033148850404

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2020
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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