Nasopharyngeal Carriage of S. Pneumoniae

Not Applicable

Recruiting

• Conditions: Children, Only; Nasopharyngeal Carriage; Antibiotic Resistant Strain
• Interventions: Other: nasopharyngeal sample; Other: Stools collection or anorectal swab samples

• Registration Number: NCT04460313
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2001-09-11
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-27
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23560

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prospective cohort	nasopharyngeal sample	Nasopharyngeal sample for each enrolled children
ESBL cohort	Stools collection or anorectal swab samples	Stool or anorectal swab samples for a subgroup of children
ESBL cohort	nasopharyngeal sample	Stool or anorectal swab samples for a subgroup of children

Primary Outcome Measures

Name	Time	Method
S. Pneumoniae colonisation to detect emerging serotypes	at inclusion	The percentage of children colonised by non vaccine serotypes -

Secondary Outcome Measures

Name	Time	Method
Detect the emergence of new serotypes	at inclusion	\> 10 Percent of isolated Sp, 5 percent of carrier children
For the ancillary study, the resistance of E. coli (ESBL) will be evaluated.	at inclusion	Assessment of E. coli (ESBL) resistance.
Detect the emergence of resistance S. pneumoniae	at inclusion	Percentage of penicillin resistant S. pneumoniae
Evaluation of the rhinopharyngeal carriage of other bacteria	at inclusion	Haemophilus influenzae, Moraxella Catarrhalis, and Staphylococcus aureus in AOM group and healthy children.

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France