Bacteriological Evaluation of Children With Otorrhea

March 17, 2026 updated by: Association Clinique Thérapeutique Infantile du val de Marne

Bacteriological Evaluation of Spontaneous Otorrhea in Children

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 15 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all children from 3 months to 15 years old with otorrhea

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective cohort
Middle ear fluid sample for each enrrolled children
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.
Other Names:
  • middle ear fluid sample for molecular sequencing analysis
  • middle ear fluid sample for Rapid Diagnostic Test (RDT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at inclusion
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.
at inclusion
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.
at inclusion
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.
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Investigators

  • Study Director: Robert Cohen, Association Clinique et Thérapeutique Infantile du Val de Marne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT0315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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