Bacteriological Evaluation of Children With Otorrhea

Recruiting

• Conditions: Otorrhea
• Interventions: Other: middle ear fluid sample

• Registration Number: NCT04807660
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

Brief 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 41 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).

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohort	middle ear fluid sample	Middle ear fluid sample for each enrrolled children

Primary Outcome Measures

Name	Time	Method
Bacteria identification	at inclusion	The percentage of children with otopathogens

Secondary Outcome Measures

Name	Time	Method
Describe the serotypes of S. pneumoniae	at inclusion	percentage of each serotype
Describe the resistance of heamophilus influenzae	at inclusion	percentage of resistant h. inlfuenzae

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France