Bacteriological Evaluation of Children With Otorrhea
ConditionOtorrhea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-15
SponsorAssociation Clinique Thérapeutique Infantile du val de Marne
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
children from 3 months to 15 years old
with otorrhea
signed parents consent
Disqualifiers
children under 3 months
children > 15 years old
Trial population
all children from 3 months to 15 years old with otorrhea
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
middle ear fluid sample for bacterial analysis (conventional microbiology analysis)
Other interventionA middle ear fluid sample will be collected from each enrolled child for the third analysis procedure.
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Prospective cohort1 intervention
Trial outcomes
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.
Time frame
at inclusionSecondary outcomes
1
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.
Time frame
at inclusion2
Clinical Characteristics of Treatment Failure or Recurrence in Children with AOM
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.
Time frame
at inclusion3
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.
Time frame
at inclusion4
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.
Time frame
at inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov