Children's nasal carriage of Streptococcus pneumoniae
Observatory of Streptococcus Pneumoniae Nasopharyngeal Carriage in Infants With Acute Otitis Media (AOM) and in Healthy Children"
This project will test whether pneumococcal vaccines changed which Streptococcus pneumoniae types children carry in their noses and whether those bacteria became more resistant to antibiotics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25760 (estimated) |
| Ages | 6 Months to 15 Years |
| Sex | All |
| Sponsor | Association Clinique Thérapeutique Infantile du val de Marne Academic / other |
| Locations | 1 site (Créteil) |
| Trial ID | NCT04460313 on ClinicalTrials.gov |
What this trial studies
Beginning in 2001, pediatricians in the ACTIV network across France enrolled children with suppurative acute otitis media (ages 6–36 months) and a separate group of healthy children (ages 6 months–15 years) during the October–June seasons each year. All participants had nasopharyngeal samples collected, with optional stool or anorectal swabs and an ancillary subgroup tested for ESBL-producing E. coli. Collected samples were serotyped and tested for antibiotic susceptibility to detect shifts in serotype distribution and resistance patterns after introduction of 7- and 13-valent pneumococcal conjugate vaccines. The study was conducted in outpatient pediatric settings with standardized sample collection and laboratory analysis over multiple years.
Who should consider this trial
Good fit: Ideal candidates are children seen in participating outpatient pediatric clinics who are either 6–36 months with suppurative acute otitis media or healthy children aged 6 months–15 years, whose parents provide consent and who have not taken antibiotics within 7 days before enrollment.
Not a fit: Children with severe underlying disease, those enrolled in the study in the prior 12 months, those with bullous myringitis, or those recently treated with antibiotics are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help guide vaccine policy and antibiotic prescribing to reduce resistant pneumococcal infections in children.
How similar studies have performed: Other national and regional surveillance studies have documented vaccine-driven serotype shifts and changes in pneumococcal antibiotic resistance, so this approach is consistent with prior successful surveillance efforts.
Eligibility criteria
Show full inclusion / exclusion criteria
children seen on an outpatient Inclusion Criteria: * 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 * informed consent from parents or guardians * Children who haven't received antibiotic treatment within 7 days before enrollment, Exclusion Criteria: * severe underlying disease, * inclusion in the study during the previous 12 months * Children with bullous myringitis cannot be included.
Where this trial is running
Créteil
- Activ — Créteil, France (Recruiting)
Study contacts
- Principal investigator: Robert Cohen, MD — Association Clinique Thérapeutique Infantile du val de Marne
- Study coordinator: Corinne Levy, MD
- Email: corinne.levy@activ-france.fr
- Phone: 0033148850404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.