Achromobacter Spp: Description of Epidemiology and Resist... | NCT04483232

Studies
Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.

NCT04483232

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Unknown status

Last Update Posted

Jul 23, 2020Actual

Enrollment

1,800Estimated

Phase

Not provided

Conditions

Achromobacter
Epidemiology
Chronic Ear Infection

Interventions

Ear canal swab

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2020Estimated

Primary Completion Date

Aug 2020Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Jul 17, 2020

First Submission Date that Met QC Criteria

Jul 22, 2020

First Posted Date

Jul 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2020

Last Update Posted Date

Jul 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Subjects			Biological: Ear canal swab
Patients with ear infections			Biological: Ear canal swab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ear canal swab	Biological	Ear canal swab	Healthy Subjects Patients with ear infections

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

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample