NCT04807660

Bacteriological Evaluation of Children With Otorrhea

Bacteriological Evaluation of Spontaneous Otorrhea in Children

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Association Clinique Thérapeutique Infantile du val de Marne · Academic / Other
• Sex: All
• Age: 3 Months – 15 Years
• Healthy volunteers: Not accepted

Summary

After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). The aim of this study was to describe the bacteriological causes of SPTM several years after PCV13 implementation, in 2010.

Detailed description

Since October 2015, children with spontaneous perforation of the tympanic membrane (SPTM) are prospectively enrolled by 20 pediatricians who are part of a research and teaching network (ACTIV, Association Clinique et Thérapeutique Infantile du Val de Marne \[Clinical and Therapeutic Association of Val de Marne\]) throughout France. For some patients, otorrhea is the first manifestation of AOM; for others, otorrhea occurred after AOM treatment failure or recurrence. Failure (non-responsive AOM) is defined as otorrhea appearing despite at least 48 hr of antibiotics or recurring less than 4 days after the end of antibiotic treatment. Recurrence is defined by the appearance of otorrhea 4 to 30 days after the end of antibiotic treatment for AOM. Middle ear fluid (MEF) is obtained by sampling spontaneous discharge according to clinical practice guidelines. MEF specimens are obtained with cotton-tipped wire swabs, immediately placed in transport medium (Copan Venturi Transystem®, Brescia, Italy), and transported within 48 hr to one of the two centralized microbiology laboratories (Robert Debré Hospital or National Centre for Pneumococci at European Georges Pompidou Hospital, Paris, France).

Conditions

• Otorrhea

Interventions

Type	Name	Description
OTHER	middle ear fluid sample for bacterial analysis (conventional microbiology analysis)	A middle ear fluid sample will be collected from each enrolled child for the third analysis procedure.

Timeline

• Start date: 2015-10-01
• Primary completion: 2028-10-31
• Completion: 2028-10-31
• First posted: 2021-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: France