Nasopharyngeal Carriage of S. Pneumoniae

Association Clinique Thérapeutique Infantile du val de Marne23,560 enrolled

Overview

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.

Since September 2001, 121 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 24 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 children were enrolled for assessment of E. coli (ESBL) resistance.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

23,560

Conditions

Nasopharyngeal Carriage Children, Only Antibiotic Resistant Strain

Interventions

nasopharyngeal sampleOTHER

Nasopharyngeal swabs from children with acute otitis media aged 6 to 24 months. The swabs were analyzed by the French National Reference Centre for Pneumococci.

Stools collection or anorectal swab samplesOTHER

For a subgroup of children stools samples or anorectal swab samples were collected for assessment of E. coli (ESBL) resistance

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * both sexes * suffering from suppurative AOM * age: 6 months to 24 months for AOM * age: 6 months to 15 years for healthy children * informed consent from parents or guardians Exclusion Criteria: * Children with antibiotic treatment within 7 days before enrolment, * severe underlying disease, * inclusion in the study during the previous 12 months

Locations (1)

ACTIV

Créteil, France

RECRUITING

Outcomes

Primary Outcomes

S. Pneumoniae colonisation to detect emerging serotypes

The percentage of children colonised by non vaccine serotypes -

Time frame: at inclusion

Secondary Outcomes

Detect the emergence of resistance S. pneumoniae

Percentage of penicillin resistant S. pneumoniae

Time frame: at inclusion

Evaluation of the rhinopharyngeal carriage of other bacteria

Haemophilus influenzae, Moraxella Catarrhalis, and Staphylococcus aureus in AOM group and healthy children.

Time frame: at inclusion

Detect the emergence of new serotypes

\> 10 Percent of isolated Sp, 5 percent of carrier children

Time frame: at inclusion

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

Assessment of E. coli (ESBL) resistance.

Time frame: at inclusion

Central Contacts

Corinne Levy, MD

CONTACT

0033148850404 corinne.levy@activ-france.fr

Stéphane Béchet, MsC

CONTACT

0033148850404 stephane.bechet@activ-france.fr

Data from ClinicalTrials.gov

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