Bacteriological Evaluation of Children With Otorrhea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: middle ear fluid sample for bacterial analysis (conventional microbiology analysis).
- Who it may be relevant to
- Registry conditions: Otorrhea. Basic parameters: 3 months — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bacteriological Evaluation of Spontaneous Otorrhea in Children
Overview
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
- 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.
Primary outcome measures
- Microbiological Profiles of Spontaneous Otorrhea in Children [Time frame: at inclusion]
Secondary outcome measures (4)
- Descriptive analysis of patient characteristics according to bacteriological Profiles [Time frame: at inclusion]
- Clinical Characteristics of Treatment Failure or Recurrence in Children with AOM [Time frame: at inclusion]
- Microbiota Analysis of Spontaneous Otorrhea in Children [Time frame: at inclusion]
- Comparison Between Rapid Diagnostic Test (RDT) and Laboratory Results [Time frame: at inclusion]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- ACTIV — Créteil
Publications
- Levy C, Varon E, Ouldali N, Wollner A, Thollot F, Corrard F, Werner A, Bechet S, Bonacorsi S, Cohen R. Bacterial causes of otitis media with spontaneous perforation of the tympanic membrane in the era of 13 valent pneumococcal conjugate vaccine. PLoS One. 2019 Feb 1;14(2):e0211712. doi: 10.1371/journal.pone.0211712. eCollection 2019. PMID 30707730
- Assad Z, Cohen R, Varon E, Levy C, Bechet S, Corrard F, Werner A, Ouldali N, Bonacorsi S, Rybak A. Antibiotic Resistance of Haemophilus influenzae in Nasopharyngeal Carriage of Children with Acute Otitis Media and in Middle Ear Fluid from Otorrhea. Antibiotics (Basel). 2023 Nov 8;12(11):1605. doi: 10.3390/antibiotics12111605. PMID 37998807
- Levy C, Varon E, Bidet P, Bechet S, Batard C, Wollner A, Thollot F, Bonacorsi S, Cohen R. Otorrhea bacterial profile, epidemiology before widespread use of the third-generation pneumococcal conjugate vaccine in French children, a prospective study from 2015 to 2023. Infect Dis Now. 2023 Sep;53(6):104738. doi: 10.1016/j.idnow.2023.104738. Epub 2023 Jun 17. PMID 37331698
- Cohen R, Varon E, Bidet P, Cohen JF, Bechet S, Couloigner V, Michot AS, Guiheneuf C, Bonacorsi S, Levy C. Diagnostic Accuracy of Group A Streptococcus Rapid Antigen Detection Test on Middle Ear Fluid in Children With Acute Otitis Media With Spontaneous Perforation: A Prospective Multicenter Evaluation. Pediatr Infect Dis J. 2023 Sep 1;42(9):816-818. doi: 10.1097/INF.0000000000004009. Epub 2023 Jun PMID 37368992
Identifiers
NCT: NCT04807660 · ACT0315