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Nasopharyngeal Carriage of S. Pneumoniae

ConditionsNasopharyngeal CarriageChildren, OnlyAntibiotic Resistant Strain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorAssociation Clinique Thérapeutique Infantile du val de Marne

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

severe underlying disease,

inclusion in the study during the previous 12 months

Children with bullous myringitis cannot be included.

Trial design

Design model

Single group

Treatments tested in this trial

  • nasopharyngeal sample (mandatory)

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

25,760 Participants
are divided into 3 treatment groups
Group A: prospective cohort: Main studyOther 1 intervention
Group B: ESBL cohort- Ancillary studyOther 3 interventions
Group C: Optional Nasopharyngeal sampleOther 2 interventions

Trial outcomes

Primary outcomes

1

S. Pneumoniae colonisation

Percentage of children colonised by S. Pneumoniae

Time frame
at inclusion
2

S. Pneumoniae colonisation involving to vaccine serotypes

Percentage of children colonised by vaccine serotypes

Time frame
at inclusion
3

S. Pneumoniae colonisation involving to non vaccine serotypes

Percentage of children colonised by non vaccine serotypes

Time frame
at inclusion
4

Reduced of sensitivity to penicillin

Percentage of Sp carriers with reduced sensitivity to penicillin

Time frame
at inclusion

Secondary outcomes

1

Detect the emergence of resistance S. pneumoniae

Percentage of penicillin resistant S. pneumoniae

Time frame
at inclusion
2

Evaluation of nasopharyngeal carriage of other bacteria

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

Time frame
at inclusion
3

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

Assessment of E. coli (ESBL) resistance.

Time frame
at inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Association Clinique Thérapeutique Infantile du val de Marne

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov
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