Evaluating bacteria in children with ear discharge
Bacteriological Evaluation of Spontaneous Otorrhea in Children
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 |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 3 Months to 15 Years |
| Sex | All |
| Sponsor | Association Clinique Thérapeutique Infantile du val de Marne Academic / other |
| Locations | 1 site (Créteil) |
| Trial ID | NCT04807660 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 months to 15 years who are experiencing otorrhea.
Not a fit: Patients under 3 months or over 15 years old will not benefit from this study.
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 performed: Other studies have shown success in evaluating bacterial causes of ear infections, but this specific approach post-vaccination is relatively novel.
Eligibility criteria
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 this trial is running
Créteil
- Activ — Créteil, France (Recruiting)
Study contacts
- Study coordinator: Corinne Levy, MD
- Email: corinne.levy@activ-france.fr
- Phone: 0033148850404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.