RecruitingOBSERVATIONAL

Bacteriological Evaluation of Children With Otorrhea

This study is investigating the bacteria responsible for ear discharge (otorrhea) in children. Ear infections are still very common in children, and sometimes the ear drum can burst, leading to discharge. While a vaccine (pneumococcal conjugate vaccine) has helped reduce some ear infections, doctors want to understand what bacteria are now causing these specific cases of ear discharge. They are collecting samples of the ear fluid from children aged 3 months to 15 years who have discharge from a burst eardrum. This will help them learn more about the current causes of these infections in France, several years after the vaccine was introduced. It's hoped this information will help doctors treat ear infections more effectively in the future.

At a glance

Status

Recruiting

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Enrolment target

1,500

Start

01 Oct 2015

Estimated completion

31 Oct 2028

Otorrhea

What is this study about?

This study is about figuring out what kind of germs (bacteria) cause ear discharge in children. Ear infections are very common in young people, and sometimes these infections can lead to a small hole in the eardrum, causing fluid to leak out. This fluid is called otorrhea.

Doctors have noticed that while a vaccine designed to protect against certain ear infection germs has helped, ear infections are still a big problem for children. This study wants to find out which other germs are now causing ear discharge, especially after the eardrum has burst. They're looking at children in France to gather this important information.

Understanding the types of germs involved is really important. It helps doctors know which treatments might work best and allows them to keep track of how common different germs are. This research could help improve how ear infections with discharge are treated for children in the future.

Key takeaways

The study investigates bacteria causing ear discharge in children.
It aims to improve understanding and treatment of ear infections.
Children aged 3 months to 15 years with ear discharge can participate.
Participation involves a single ear fluid sample collection.
No new treatments or medications are given as part of the study.
Results could help doctors treat ear infections more effectively.

Who may be eligible?

To join this study, children need to be between 3 months and 15 years old. They must also be experiencing ear discharge, which means fluid is coming out of their ear.

Parents or legal guardians will need to give their written permission for their child to take part.

Children who are younger than 3 months or older than 15 years old cannot participate in this study.

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 your child between 3 months and 15 years old?
Does your child have fluid or discharge coming from their ear?
Are you, as a parent or guardian, willing to give written permission for your child to join?
Is your child NOT younger than 3 months or older than 15 years?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, the main thing that will happen is a sample of the fluid (discharge) from their ear will be taken. This is usually done with a cotton-tipped swab, similar to a cotton bud. This fluid will then be sent to a special lab to identify the bacteria causing the infection.

There won't be any new medication given as part of this study. The sample collection is part of the usual care your child would receive for ear discharge. The overall duration of your child's involvement would be during that single visit when the sample is taken and then the sample's transport and analysis.

Potential risks and benefits

Taking part in this study generally involves very low risk, as the ear fluid sample collection is a routine part of investigating ear infections. The potential benefit is that the information gathered from your child's sample, along with others, will help doctors better understand and treat ear infections in children in the future. You are free to decide not to take part or to withdraw your child from the study at any time without giving a reason, and this will not affect your child's medical care in any way.

Locations (1)

ACTIV
Verified postcode
Créteil, France· Recruiting

Common questions

What is 'otorrhea'?

Otorrhea is simply the medical term for fluid or discharge coming out of the ear.

What is an 'ear drum perforation'?

This is when there's a small tear or hole in the eardrum, often caused by an ear infection, which can allow fluid to escape.

Will my child receive any new medication in this study?

No, this study does not involve giving any new medications. It's focused on understanding what causes the infection.

How long will my child be involved in the study?

Your child's involvement will primarily be during the time when the ear fluid sample is collected as part of their routine care.

Who is paying for this study?

The information provided does not specify who is funding this research.

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.