Otorrhea
Conditions
Keywords
otorrhea, children, spontaneous perforation of the tympanic membrane, ambulatory, streptococcus pneumoniae, heamophilus influenzae, moraxella catarrhalis, streptococcus pyogenes
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 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).
Interventions
OTHERmiddle 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.
Sponsors
Association Clinique Thérapeutique Infantile du val de Marne
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Profiles of Spontaneous Otorrhea in Children | at inclusion | To determine the microbiological profiles of spontaneous otorrhea in children by identifying the bacterial pathogens present in collected samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive analysis of patient characteristics according to bacteriological Profiles | at inclusion | To describe, for each bacterial species identified, patient characteristics according to demographics, vaccinal and general medical history, AOM history, and sample collection conditions. |
| Clinical Characteristics of Treatment Failure or Recurrence in Children with AOM | at inclusion | To describe the clinical characteristics of treatment failure or recurrence in children with acute otitis media (AOM), according to the identified bacteria, including symptom severity, duration, and observed clinical signs. |
| Microbiota Analysis of Spontaneous Otorrhea in Children | at inclusion | To analyze the microbiota involved in spontaneous otorrhea and bacterial interactions using molecular biology techniques and compare these results with conventional bacteriological methods. |
| Comparison Between Rapid Diagnostic Test (RDT) and Laboratory Results | at inclusion | To compare the results of the rapid diagnostic test (RDT) with those obtained from samples analyzed in the laboratory using standard bacteriological methods. |
Countries
France
Contacts
CONTACTCorinne Levy, MD
CONTACTStéphane Béchet, MSc
STUDY_DIRECTORRobert Cohen
Association Clinique et Thérapeutique Infantile du Val de Marne
Outcome results
None listed