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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04483232
Other study ID # AMOUREUX FPA 2020
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2020
Est. completion date August 2020

Study information

Verified date July 2020
Source Centre Hospitalier Universitaire Dijon
Contact Lucie AMOUREUX
Phone 03.80.29.56.86
Email lucie.amoureux@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus Achromobacter is not known in these conditions. An epidemiological study including a large number of patients is needed to compare the prevalence of these bacteria in sick and healthy subjects, and to highlight the characteristics of the strains and the factors favouring their emergence.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1800
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years and older
Eligibility Inclusion Criteria:

- Person or parent who has given his or her non-opposition

- Person over 10 years of age

- Sick Subjects Group :

diagnosis of chronic infection by an ENT specialist doctor if patient already included: new episode > 3 months after the complete clinical recovery from the previous episode observed by the ENT doctor - Healthy group: no ear infection in the last 6 months and no antibiotics in the previous month.

Exclusion Criteria:

-

Study Design


Intervention

Biological:
Ear canal swab
Ear canal swab

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Achromobacter positive sample number Through study completion, an average of 3 years
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