NCT04460313 Nasopharyngeal Carriage of S. Pneumoniae
| NCT ID | NCT04460313 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Association Clinique Thérapeutique Infantile du val de Marne |
| Condition | Nasopharyngeal Carriage |
| Study Type | INTERVENTIONAL |
| Enrollment | 25,760 participants |
| Start Date | 2001-09-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25,760 participants in total. It began in 2001-09-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Robert Cohen, MD
PRINCIPAL INVESTIGATOR
Association Clinique Thérapeutique Infantile du val de Marne
Frequently Asked Questions
Who can join the NCT04460313 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 15 Years, studying Nasopharyngeal Carriage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04460313 currently recruiting?
Yes, NCT04460313 is actively recruiting participants. Contact the research team at corinne.levy@activ-france.fr for enrollment information.
Where is the NCT04460313 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT04460313 clinical trial?
NCT04460313 is sponsored by Association Clinique Thérapeutique Infantile du val de Marne. The principal investigator is Robert Cohen, MD at Association Clinique Thérapeutique Infantile du val de Marne. The trial plans to enroll 25,760 participants.