What is this study trying to find out about otorrhea in children?

This study aims to identify the bacteria that cause spontaneous ear discharge (otorrhea) in children. Researchers want to understand these causes several years after the pneumococcal vaccine was introduced. This helps improve knowledge about ear infections in childhood and is sponsored by the Association Clinique Thérapeutique Infantile du val de Marne.

Who may be eligible for this otorrhea clinical trial?

Children aged between 3 months and 15 years who currently have otorrhea may be eligible. Parental consent is also required. Children younger than 3 months or older than 15 years are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this otorrhea clinical trial?

Study-related care, including the sample collection and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect their study-related procedures to be covered by the trial.

Actively Recruiting

Age: 3Months - 15Years

All Genders

ID04807660

Bacteriological Evaluation of Spontaneous Otorrhea in Children

Led by Association Clinique Thérapeutique Infantile du val de Marne · Updated on 2026-03-19

1500

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying children who experience spontaneous perforation of the tympanic membrane (SPTM), a condition where the eardrum tears and causes ear discharge (otorrhea). This study aims to understand the bacterial causes of this condition several years after the introduction of the pneumococcal conjugate vaccine (PCV13) in 2010. Although the number of acute otitis media (AOM) cases has decreased since the vaccine, SPTM still occurs in some children and needs further investigation. Children with SPTM are enrolled by pediatricians across France and a sample of middle ear fluid is collected using a cotton-tipped wire swab from the spontaneous ear discharge. This fluid is then transported to specialized microbiology labs for bacterial analysis. The study captures cases where otorrhea appears as the first sign of AOM or after treatment failure or recurrence of AOM symptoms. Participants undergo sample collection during their inclusion visit, and researchers analyze the microbiological profiles of the ear discharge. They also study patient characteristics, clinical features of treatment failure or recurrence, and compare rapid diagnostic test results with laboratory findings. The study involves children aged 3 months to 15 years and continues until October 2028, aiming to improve understanding of ear infections in children.

CONDITIONS

Brief Title

Bacteriological Evaluation of Children With Otorrhea

Who Can Participate

Age: 3Months - 15Years

All Genders

Eligibility Criteria

You may qualify if you...

Children from 3 months to 15 years old
Children with otorrhea (ear discharge)
Signed parental consent obtained

You will not qualify if you...

Children under 3 months old
Children older than 15 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At inclusion

Participants undergo collection of a middle ear fluid sample for bacterial analysis according to clinical practice guidelines.

1 visit (in-person)

Surveillance

Duration - Ongoing during study participation

Participants who undergo routine care are observed, with data collected on microbiological profiles and clinical characteristics.

No additional visits required for study purposes

Trial Site Locations

Total: 1 location

ACTIV

Créteil, France, 94000

Actively Recruiting

Loading map...

Research Team

Corinne Levy, MD

Stéphane Béchet, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Bacterial causes of otitis media with spontaneous perforation of the tympanic membrane in the era of 13 valent pneumococcal conjugate vaccine.

Corinne Levy, Emmanuelle Varon, Naim Ouldali...

https://pubmed.ncbi.nlm.nih.gov/30707730

Antibiotic Resistance of Haemophilus influenzae in Nasopharyngeal Carriage of Children with Acute Otitis Media and in Middle Ear Fluid from Otorrhea.

Zein Assad, Robert Cohen, Emmanuelle Varon...

https://pubmed.ncbi.nlm.nih.gov/37998807

Otorrhea bacterial profile, epidemiology before widespread use of the third-generation pneumococcal conjugate vaccine in French children, a prospective study from 2015 to 2023.

Corinne Levy, Emmanuelle Varon, Philippe Bidet...

https://pubmed.ncbi.nlm.nih.gov/37331698

Diagnostic Accuracy of Group A Streptococcus Rapid Antigen Detection Test on Middle Ear Fluid in Children With Acute Otitis Media With Spontaneous Perforation: A Prospective Multicenter Evaluation.

Robert Cohen, Emmanuelle Varon, Philippe Bidet...

https://pubmed.ncbi.nlm.nih.gov/37368992

Bacteriological Evaluation of Spontaneous Otorrhea in Children

On this page