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NCT Number: NCT04807660

Bacteriological Evaluation of Children With Otorrhea

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.

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Key information

Conditions

Otorrhea

Age range

3 month–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: middle ear fluid sample for molecular sequencing analysis, middle ear fluid sample for Rapid Diagnostic Test (RDT)

Primary outcomes

  1. Microbiological Profiles of Spontaneous Otorrhea in Children

    Time frame: at inclusion

    To determine the microbiological profiles of spontaneous otorrhea in children by identifying the bacterial pathogens present in collected samples.

Secondary outcomes

  1. Descriptive analysis of patient characteristics according to bacteriological Profiles

    Time frame: 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.

  2. Clinical Characteristics of Treatment Failure or Recurrence in Children with AOM

    Time frame: 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.

  3. Microbiota Analysis of Spontaneous Otorrhea in Children

    Time frame: 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.

  4. Comparison Between Rapid Diagnostic Test (RDT) and Laboratory Results

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Corinne Levy, MD

CONTACT

[email protected]

0033148850404

Stéphane Béchet, MSc

CONTACT

[email protected]

0033148850404

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Registry information

Official study title

Bacteriological Evaluation of Spontaneous Otorrhea in Children

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Mar 19, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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