Clinical trial Recruiting at 1 site Observational Ages 3 Months to 15

Evaluating bacteria in children with ear discharge

Official title: Bacteriological Evaluation of Spontaneous Otorrhea in Children

Run by Association Clinique Thérapeutique Infantile du val de Marne · NCT04807660 · Data updated 2026-11-12

This study is trying to find out what types of bacteria are causing ear infections in children with ear discharge after they’ve received the pneumococcal vaccine.

Quick facts

Study typeObservational
Ages3 Months to 15 Years
SexAll
Enrollment1500 (estimated)
SponsorAssociation Clinique Thérapeutique Infantile du val de Marne
Academic / other
Locations1 site (Créteil)
StatusRecruiting
StartedOctober 1, 2015
Main results expectedOctober 31, 2028
Study endsOctober 31, 2028
Registry record updatedOctober 29, 2026
Trial IDNCT04807660 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 3 months to 15 years who are experiencing otorrhea.

Probably not a fit

Patients under 3 months or over 15 years old will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify the bacteriological causes of spontaneous perforation of the tympanic membrane (SPTM) in children, several years after the implementation of the pneumococcal conjugate vaccine. Children aged 3 months to 15 years with otorrhea are prospectively enrolled by pediatricians across France. The study involves collecting middle ear fluid samples from these children to analyze the presence of bacteria, particularly focusing on cases where otorrhea is linked to acute otitis media (AOM). The findings will help understand the evolving bacterial landscape in pediatric ear infections post-vaccination.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for children suffering from ear infections.

How similar studies have gone: Other studies have shown success in evaluating bacterial causes of ear infections, but this specific approach post-vaccination is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* children from 3 months to 15 years old
* with otorrhea
* signed parents consent

Exclusion Criteria:

* children under 3 months
* children \> 15 years old

Where it's running

  • Activ
    Créteil, France
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.