Bacteriological Evaluation of Children With Otorrhea

Study Overview
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Brief Summary
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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
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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).

Official Title
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Bacteriological Evaluation of Spontaneous Otorrhea in Children

Conditions
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Otorrhea

Intervention / Treatment
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* Other: middle ear fluid sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective cohort<br>Middle ear fluid sample for each enrrolled children | Other: middle ear fluid sample<br>* middle ear fluid sample for each enrrolled children<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteria identification | The percentage of children with otopathogens | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the serotypes of S. pneumoniae | percentage of each serotype | at inclusion | 
| Describe the resistance of heamophilus influenzae | percentage of resistant h. inlfuenzae | at inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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otorrrhea, children, spontaneous perforation of the tympanic membrane, ambulatory, streptococcus pneumoniae, heamophilus influenzae, moraxella catarrhalis, streptococcus pyogenes