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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04807660
Other study ID # ACT0315
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2015
Est. completion date October 1, 2025

Study information

Verified date January 2024
Source Association Clinique Thérapeutique Infantile du val de Marne
Contact Corinne Levy, MD
Phone 0033148850404
Email corinne.levy@activ-france.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date October 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender All
Age group 3 Months to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
middle ear fluid sample
middle ear fluid sample for each enrrolled children

Locations

Country Name City State
France ACTIV Créteil

Sponsors (1)

Lead Sponsor Collaborator
Association Clinique Thérapeutique Infantile du val de Marne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bacteria identification The percentage of children with otopathogens at inclusion
Secondary Describe the serotypes of S. pneumoniae percentage of each serotype at inclusion
Secondary Describe the resistance of heamophilus influenzae percentage of resistant h. inlfuenzae at inclusion
See also
  Status Clinical Trial Phase
Withdrawn NCT03347461 - Otiprio Versus Ciprodex Tympanostomy Tube Outcomes Phase 4
Withdrawn NCT00956748 - N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media Phase 4
Terminated NCT01111877 - Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years N/A
Terminated NCT02817347 - A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea Phase 1/Phase 2