NCT04483232

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

July 17, 2020

Last Update Submit

July 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Achromobacter positive sample number

    Through study completion, an average of 3 years

Study Arms (2)

Healthy Subjects

Biological: Ear canal swab

Patients with ear infections

Biological: Ear canal swab

Interventions

Ear canal swabBIOLOGICAL

Ear canal swab

Healthy SubjectsPatients with ear infections

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 23, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations