RecruitingNAINTERVENTIONAL

Nasopharyngeal Carriage of S. Pneumoniae

This research wants to understand if two vaccines, which protect against a common bacterium called *Streptococcus pneumoniae*, have changed the kinds of this bacteria found in children since they were introduced in 2001 and 2010. Researchers are also checking if these bacteria have become harder to treat with antibiotics. This is important because *Streptococcus pneumoniae* can cause ear infections and other illnesses. The study has been running since 2001, with paediatricians across France collecting samples from children with ear infections and healthy children. The results will help authorities like the European Agency for Medicines understand the long-term effects of these vaccines on children's health and antibiotic resistance.

At a glance

Status

Recruiting

Phase

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Enrolment target

25,760

Start

11 Sep 2001

Estimated completion

31 Dec 2026

Nasopharyngeal Carriage Children, Only Antibiotic Resistant Strain

What is this study about?

Imagine your child gets an ear infection. Often, a tiny germ called *Streptococcus pneumoniae* is the cause. We have vaccines that help protect against many types of this germ. These vaccines were first introduced in 2001 and an updated version in 2010.

This study is like a long-term check-up to see how well these vaccines are working and what impact they've had. Researchers want to know if the vaccines have changed which types of *Streptococcus pneumoniae* germs are now common in children. They are also looking at whether these germs have become more resistant to antibiotics, which means antibiotics might not work as well to treat them.

By following children for many years, this study helps us understand the bigger picture of how vaccines affect common germs and antibiotic resistance. This information is really important for doctors and health authorities to make sure we're using the best approaches to keep children healthy and effectively treat infections in the future.

Key takeaways

Looks at how vaccines affect types of bacteria in children.
Investigates if bacteria are becoming antibiotic resistant.
Involves collecting samples from children's noses/throats.
Helps understand long-term vaccine effects on child health.
Focuses on children aged 6 months to 15 years in France.

Who may be eligible?

This study is looking for two main groups of children in France. The first group includes children aged 6 months to 3 years (36 months) who have painful ear infections with a fever. The second group is healthy children aged 6 months up to 15 years old. For both groups, children of any gender can take part.

To be included, a child must not have been given antibiotics in the 7 days before joining the study. Also, their parents or guardians must give their permission for the child to participate.

Children cannot join if they have a serious ongoing health problem, if they have already taken part in this study in the last 12 months, or if they have a specific type of ear infection called bullous myringitis.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child aged between 6 months and 15 years?
Does my child have an ear infection *and* is between 6 months and 3 years old, OR is my child healthy?
Has my child NOT had antibiotics in the last 7 days?
Does my child NOT have a serious ongoing health problem?
Does my child NOT have bullous myringitis (a specific type of ear infection)?

Answer every question to see your result.

What does participation involve?

If your child takes part, a doctor will collect a sample from their nose and throat, which is called a nasopharyngeal sample. This is mandatory for all children in the study. In some cases, and if you agree, children might also be asked to provide a stool sample or have a swab taken from their bottom (anorectal swab). This is optional and not required for all children. This study does not involve taking any new medications, only collecting samples for analysis. The study has been ongoing for many years in France, with children enrolled during the academic year (October to June) so it's not a single visit study but rather an ongoing enrolment process.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers understand how vaccines are affecting children's health and antibiotic resistance, which can lead to better health strategies for all children in the future. There are very few risks involved; collecting a nasal or stool sample may cause slight, temporary discomfort. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting your child's medical care.

Locations (1)

ACTIV
Verified postcode
Créteil, France· Recruiting

Common questions

What is a nasopharyngeal sample?

It's a sample taken from the back of your child's nose and throat, usually using a soft swab, to check for germs.

What is *Streptococcus pneumoniae*?

It's a common type of bacteria that can cause infections like ear infections, pneumonia, and meningitis.

What does 'antibiotic resistant' mean?

It means that some bacteria have changed so that common antibiotics may not be able to kill them or stop them from growing as effectively.

Will my child get any special treatment in this study?

No, this study is about collecting information and samples, not about giving new treatments or medications.

Can my child leave the study at any time?

Yes, you can choose to withdraw your child from the study at any point, and it won't affect their regular medical care.

How to find out more

Corinne Levy, MD

corinne.levy@activ-france.fr 0033148850404 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.