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Bacteriological Evaluation of Children With Otorrhea

NCT ID: NCT04807660

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2025-10-01

Brief Summary

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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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Detailed Description

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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).

Conditions

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Otorrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective cohort

Middle ear fluid sample for each enrrolled children

middle ear fluid sample

Intervention Type OTHER

middle ear fluid sample for each enrrolled children

Interventions

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middle ear fluid sample

middle ear fluid sample for each enrrolled children

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Cohen

Role: STUDY_DIRECTOR

Association Clinique et Thérapeutique Infantile du Val de Marne

Locations

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ACTIV

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Corinne Levy, MD

Role: CONTACT

[email protected]
0033148850404

Stéphane Béchet, MSc

Role: CONTACT

[email protected]
0033148850404

Facility Contacts

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Corinne Levy, MD

Role: primary

[email protected]
0033148850404

Stéphane Béchet, MSc

Role: backup

[email protected]
0033148850404

References

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Cohen R, Varon E, Bidet P, Cohen JF, Bechet S, Couloigner V, Michot AS, Guiheneuf C, Bonacorsi S, Levy C. Diagnostic Accuracy of Group A Streptococcus Rapid Antigen Detection Test on Middle Ear Fluid in Children With Acute Otitis Media With Spontaneous Perforation: A Prospective Multicenter Evaluation. Pediatr Infect Dis J. 2023 Sep 1;42(9):816-818. doi: 10.1097/INF.0000000000004009. Epub 2023 Jun 22.

Reference Type DERIVED
PMID: 37368992 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/30707730/

Bacterial causes of otitis media with spontaneous perforation of the tympanic membrane in the era of 13 valent pneumococcal conjugate vaccine

Other Identifiers

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ACT0315

Identifier Type: -

Identifier Source: org_study_id

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