NCT04460313

Nasopharyngeal Carriage of S. Pneumoniae

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25,760 (estimated)
• Sponsor: Association Clinique Thérapeutique Infantile du val de Marne · Academic / Other
• Sex: All
• Age: 6 Months – 15 Years
• Healthy volunteers: Accepted

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, 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.

Conditions

• Nasopharyngeal Carriage
• Children, Only
• Antibiotic Resistant Strain

Interventions

Type	Name	Description
OTHER	nasopharyngeal sample (mandatory)	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.
OTHER	Stools collection or anorectal swab samples (optional)	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
OTHER	nasopharyngeal sample (optional)	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.

Timeline

• Start date: 2001-09-11
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-07-07
• Last updated: 2026-03-19

Locations

1 site across 1 country: France