AchromobacterAERIONCT04483232
Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.
An observational study of Achromobacter and Epidemiology, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achromobacter, Epidemiology, Chronic Ear Infection
- What is being tested?
- Ear canal swab
- How many people
- 1,800 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2020to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Dijon Bourgogne
Dijon, 21000
Lucie AMOUREUX, 03.80.29.56.86 ext. +33, lucie.amoureux@chu-dijon.fr
About this study
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.
- Conditions
- Achromobacter, Epidemiology, Chronic Ear Infection
- Being tested
- Ear canal swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear canal swabBiological
Ear canal swab
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Not described Receives: Biological: Ear canal swab | |
| Patients with ear infections | Not described Receives: Biological: Ear canal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achromobacter positive sample number
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study startAug 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchromobacterStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483232
- Sponsor's protocol ID
- AMOUREUX FPA 2020
- Acronym
- AERIO
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.
- ClinicalTrials.gov ID
- NCT04483232
- Acronym / sponsor ID
- AERIO / AMOUREUX FPA 2020
- Conditions
- Achromobacter, Epidemiology, Chronic Ear Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Biological: Ear canal swab |
| Patients with ear infections | – | Biological: Ear canal swab |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ear canal swabEar canal swab | Biological | Healthy Subjects, Patients with ear infections |
Primary outcome
Achromobacter positive sample number
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
Related trials for Achromobacter
RecruitingPhase 1
Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection
Cystic Fibrosis (CF), Achromobacter Infection
Active, not recruitingObservational study
Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis
Cystic Fibrosis
Not yet recruitingPhase 1
Safety of Combined Intravenous Antibiotic and Bacteriophage Therapy in Adults With Cystic Fibrosis and Antibiotic-Resistant Lung Infections
CF - Cystic Fibrosis, Klebsiella Pneumoniae Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achromobacter and Epidemiology, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie AMOUREUX (03.80.29.56.86 ext. +33, lucie.amoureux@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achromobacter positive sample number (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.