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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort | Middle ear fluid sample for each enrrolled children |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| middle ear fluid sample for bacterial analysis (conventional microbiology analysis) | Other | A middle ear fluid sample will be collected from each enrolled child for the third analysis procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological Profiles of Spontaneous Otorrhea in Children | To determine the microbiological profiles of spontaneous otorrhea in children by identifying the bacterial pathogens present in collected samples. | at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analysis of patient characteristics according to bacteriological Profiles | To describe, for each bacterial species identified, patient characteristics according to demographics, vaccinal and general medical history, AOM history, and sample collection conditions. | at inclusion |
| Clinical Characteristics of Treatment Failure or Recurrence in Children with AOM |
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Inclusion Criteria:
Exclusion Criteria:
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all children from 3 months to 15 years old with otorrhea
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corinne Levy, MD | Contact | 0033148850404 | corinne.levy@activ-france.fr | |
| Stéphane Béchet, MSc | Contact | 0033148850404 | sgtephane.bechet@activ-france.fr |
| Name | Affiliation | Role |
|---|---|---|
| Robert Cohen | Association Clinique et Thérapeutique Infantile du Val de Marne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACTIV | Recruiting | Créteil | 94000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30707730 | Result | 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. | |
| 37998807 |
| Label | URL |
|---|---|
| Bacterial causes of otitis media with spontaneous perforation of the tympanic membrane in the era of 13 valent pneumococcal conjugate vaccine | View source |
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| ID | Term |
|---|---|
| D000092025 | Rapid Diagnostic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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|
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. |
| at inclusion |
| Microbiota Analysis of Spontaneous Otorrhea in Children | To analyze the microbiota involved in spontaneous otorrhea and bacterial interactions using molecular biology techniques and compare these results with conventional bacteriological methods. | at inclusion |
| Comparison Between Rapid Diagnostic Test (RDT) and Laboratory Results | To compare the results of the rapid diagnostic test (RDT) with those obtained from samples analyzed in the laboratory using standard bacteriological methods. | at inclusion |
| 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. |
| 37331698 | Result | 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. |
| 37368992 | Derived | 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 22. |
| Antibiotic Resistance of Haemophilus influenzae in Nasopharyngeal Carriage of Children with Acute Otitis Media and in Middle Ear Fluid from Otorrhea | View source |
| Otorrhea bacterial profile, epidemiology before widespread use of the third-generation pneumococcal conjugate vaccine in French children, a prospective study from 2015 to 2023 | View source |
| D000067716 | Point-of-Care Testing |
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |