RecruitingNot Applicable

Nasopharyngeal Carriage of S. Pneumoniae

France25,760 participantsStarted 2001-09-11

Plain-language 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.

Who can participate

Age range

6 Months – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

S. Pneumoniae colonisation

Timeframe: at inclusion

S. Pneumoniae colonisation involving to vaccine serotypes

Timeframe: at inclusion

S. Pneumoniae colonisation involving to non vaccine serotypes

Timeframe: at inclusion

Reduced of sensitivity to penicillin

Timeframe: at inclusion

Detect the emergence of new serotypes

Timeframe: at inclusion

Association of Pneumococcal Serotypes with Respiratory Viruses

Timeframe: at inclusion

Trial details

NCT IDNCT04460313

SponsorAssociation Clinique Thérapeutique Infantile du val de Marne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Corinne Levy, MD

0033148850404 corinne.levy@activ-france.fr

View on ClinicalTrials.gov More Nasopharyngeal Carriage trials

Plain-language summary

Who can participate

Age range

6 Months – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

S. Pneumoniae colonisation

Timeframe: at inclusion

S. Pneumoniae colonisation involving to vaccine serotypes

Timeframe: at inclusion

S. Pneumoniae colonisation involving to non vaccine serotypes

Timeframe: at inclusion

Reduced of sensitivity to penicillin

Timeframe: at inclusion

Detect the emergence of new serotypes

Timeframe: at inclusion

Association of Pneumococcal Serotypes with Respiratory Viruses

Timeframe: at inclusion