Bacteriological Evaluation of Children With Otorrhea

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04807660

Collaborator

(none)

800

Enrollment

Location

111

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Otorrhea	Other: middle ear fluid sample

Detailed Description

Since October 2015, children with spontaneous perforation of the tympanic membrane (SPTM) are prospectively enrolled by 41 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 Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Bacteriological Evaluation of Spontaneous Otorrhea in Children

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Prospective cohort Middle ear fluid sample for each enrrolled children	Other: middle ear fluid sample middle ear fluid sample for each enrrolled children

Arm

Intervention/Treatment

Prospective cohort

Middle ear fluid sample for each enrrolled children

Other: middle ear fluid sample

middle ear fluid sample for each enrrolled children

Outcome Measures

Primary Outcome Measures

Bacteria identification [at inclusion]
The percentage of children with otopathogens

Secondary Outcome Measures

Describe the serotypes of S. pneumoniae [at inclusion]
percentage of each serotype
Describe the resistance of heamophilus influenzae [at inclusion]
percentage of resistant h. inlfuenzae