Bacteriological Evaluation of Children With Otorrhea

NCT04807660 | Recruiting DMC

• 1 other identifier: ACT0315
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Otorrhea

Keywords

otorrhea; children; spontaneous perforation of the tympanic membrane; ambulatory; streptococcus pneumoniae; heamophilus influenzae; moraxella catarrhalis; streptococcus pyogenes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Descriptive analysis of patient characteristics according to bacteriological Profiles

  at inclusion

• Clinical Characteristics of Treatment Failure or Recurrence in Children with AOM

  at inclusion

• Microbiota Analysis of Spontaneous Otorrhea in Children

  at inclusion

• Comparison Between Rapid Diagnostic Test (RDT) and Laboratory Results

  at inclusion

Study Arms (1)

Prospective cohort

Middle ear fluid sample for each enrrolled children

Other: middle ear fluid sample for bacterial analysis (conventional microbiology analysis)

Interventions

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.

Also known as: middle ear fluid sample for molecular sequencing analysis, middle ear fluid sample for Rapid Diagnostic Test (RDT)

Prospective cohort

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

all children from 3 months to 15 years old with otorrhea

You may qualify if:

• children from 3 months to 15 years old
• with otorrhea
• signed parents consent

You may not qualify if:

• children under 3 months
• children \> 15 years old

Sponsors & Collaborators

• Association Clinique Thérapeutique Infantile du val de Marne: lead

Study Sites (1)

ACTIV

Créteil, 94000, France

RECRUITING

Related Publications (4)

• 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 RESULT

• 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 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.

  PMID: 37331698 RESULT

• 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.

  PMID: 37368992 DERIVED

Related Links

• Bacterial causes of otitis media with spontaneous perforation of the tympanic membrane in the era of 13 valent pneumococcal conjugate vaccine
• Antibiotic Resistance of Haemophilus influenzae in Nasopharyngeal Carriage of Children with Acute Otitis Media and in Middle Ear Fluid from Otorrhea
• Otorrhea bacterial profile, epidemiology before widespread use of the third-generation pneumococcal conjugate vaccine in French children, a prospective study from 2015 to 2023

MeSH Terms

Interventions

Rapid Diagnostic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Robert Cohen

  Association Clinique et Thérapeutique Infantile du Val de Marne

  STUDY DIRECTOR

Central Study Contacts

Corinne Levy, MD

CONTACT

0033148850404; corinne.levy@activ-france.fr

Stéphane Béchet, MSc

CONTACT

0033148850404; sgtephane.bechet@activ-france.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 19, 2021
• Study Start: October 1, 2015
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)