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 type | Observational |
|---|---|
| Ages | 3 Months to 15 Years |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Association Clinique Thérapeutique Infantile du val de Marne Academic / other |
| Locations | 1 site (Créteil) |
| Status | Recruiting |
| Started | October 1, 2015 |
| Main results expected | October 31, 2028 |
| Study ends | October 31, 2028 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT04807660 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
- Study coordinator: Corinne Levy, MD
- Email: corinne.levy@activ-france.fr
- Phone: 0033148850404
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.