Bacteriological Evaluation of Children With Otorrhea

Otorrhea Clinical Trial

Official title:

Bacteriological Evaluation of Spontaneous Otorrhea in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04807660
• Other study ID #: ACT0315
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Otorrhea

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

External Links

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