Nasopharyngeal Carriage of S. Pneumoniae

Association Clinique Thérapeutique Infantile du val de Marne

Status: Enrolling

Conditions: Nasopharyngeal Carriage; Antibiotic Resistant Strain; Children, Only

Treatments: Other: nasopharyngeal sample; Other: Stools collection or anorectal swab samples

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04460313

ACT0806

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23,560 estimated patients

Sex: All

Ages: 6 months to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23,560 participants in 2 patient groups

prospective cohort

Other group

Description:

Nasopharyngeal sample for each enrolled children

Treatment:

Other: nasopharyngeal sample

ESBL cohort

Other group

Description:

Stool or anorectal swab samples for a subgroup of children

Treatment:

Other: nasopharyngeal sample

Other: Stools collection or anorectal swab samples