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Bacteriological Evaluation of Children With Otorrhea

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ClinicalTrials.gov Identifier: NCT04807660
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Association Clinique Thérapeutique Infantile du val de Marne

Study Description
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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
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
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bacteriological Evaluation of Spontaneous Otorrhea in Children
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : October 1, 2015
Estimated Study Completion Date : January 1, 2025
Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Bacteria identification [ Time Frame: at inclusion ]
    The percentage of children with otopathogens


Secondary Outcome Measures :
  1. Describe the serotypes of S. pneumoniae [ Time Frame: at inclusion ]
    percentage of each serotype

  2. Describe the resistance of heamophilus influenzae [ Time Frame: at inclusion ]
    percentage of resistant h. inlfuenzae


Eligibility Criteria
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Ages Eligible for Study:   3 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all children from 3 months to 15 years old with otorrhea
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807660


Contacts
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Contact: Corinne Levy, MD 0033148850404 corinne.levy@activ-france.fr
Contact: Stéphane Béchet, MSc 0033148850404 sgtephane.bechet@activ-france.fr

Locations
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France
ACTIV Recruiting
Créteil, France, 94000
Contact: Corinne Levy, MD    0033148850404    corinne.levy@activ-france.fr   
Contact: Stéphane Béchet, MSc    0033148850404    stephane.bechet@activ-france.fr   
Sponsors and Collaborators
Association Clinique Thérapeutique Infantile du val de Marne
More Information
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Additional Information:

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Responsible Party: Association Clinique Thérapeutique Infantile du val de Marne
ClinicalTrials.gov Identifier: NCT04807660    
Other Study ID Numbers: ACT0315
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association Clinique Thérapeutique Infantile du val de Marne:
otorrrhea
children
spontaneous perforation of the tympanic membrane
ambulatory
 streptococcus pneumoniae
heamophilus influenzae
moraxella catarrhalis
streptococcus pyogenes