Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals. (AERIO)

July 22, 2020 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Protected adult (curatorship, guardianship)
  • Person deprived of their liberty by judicial or administrative decision
  • Pregnant, parturient or breastfeeding woman
  • Adult unable to give consent

  • For healthy subjects:

    • current ear infection or within the last 6 months
    • Antibiotics (local or systemic) taken within the previous month
  • For sick subjects who have already been included once, new episode < 3 months after the previous one

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Subjects
Biological: Ear canal swab
Ear canal swab
Patients with ear infections
Biological: Ear canal swab
Ear canal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achromobacter positive sample number
Time Frame: Through study completion, an average of 3 years
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (ACTUAL)

July 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMOUREUX FPA 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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