Bone and Joint InfectionNCT03768635
Necrotizing External Otitis : Study in a Regional Bone and Joint Infection Reference Center
An observational study of Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The malignant external otitis is a rare disease which arises more frequently at the elderly and the diabetics patients. To our knowledge, there are few data and it is not wellc known byclinicians. Nevertheless it exposes to neurological complications potentially serious and crippling. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Bone and Joint Infection
- What is being tested?
- necrotizing external otitis
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2006to 31 Jul 2018
- 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 18 to 95 years
- All sexes
- Adult, Older adult
Study population: patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center between 01/01/2006 and 31/01/2018
Who may be able to join
- patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Necrotizing External Otitis : Study in a Regional Bone and Joint Infection
The malignant external otitis is a rare disease which arises more frequently at the elderly and the diabetics patients. To our knowledge, there are few data and it is not wellc known byclinicians. Nevertheless it exposes to neurological complications potentially serious and crippling.
- Conditions
- Bone and Joint Infection
- Being tested
- necrotizing external otitis
- Keywords
- otitis
- Medical subject headings
- Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
necrotizing external otitisOther
description of necrotizing external otitis
| Study group | Role | What they receive |
|---|---|---|
| Necrotizing external otitis | description of necrotizing external otitis Receives: Other: necrotizing external otitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of necrotizing external otitis
description of necrotizing external otitis: patients, profile of the bacterium, medical and chirurgical treatment, rate
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes (2)
Rate of Treatment Failure
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor.
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Duration of antibiotics
Description of the strategies of antibiotic treatments used (double-agent therapy, monotherapy, duration)
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Jan 2006
- Primary completion31 Jan 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
- Investigators
- Tristan Ferry, Md, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768635
- Sponsor's protocol ID
- 18-284
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necrotizing External Otitis : Study in a Regional Bone and Joint Infection
- ClinicalTrials.gov ID
- NCT03768635
- Acronym / sponsor ID
- 18-284
- Conditions
- Bone and Joint Infection
- Keywords
- otitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 7 Dec 2018 (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.
The malignant external otitis is a rare disease which arises more frequently at the elderly and the diabetics patients. To our knowledge, there are few data and it is not wellc known byclinicians. Nevertheless it exposes to neurological complications potentially serious and crippling.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Necrotizing external otitis | – | Other: necrotizing external otitisdescription of necrotizing external otitis |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center between 01/01/2006 and 31/01/2018
Key inclusion criteria (1 listed)
- patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| necrotizing external otitisdescription of necrotizing external otitis | Other | Necrotizing external otitis |
Primary outcome
Rate of necrotizing external otitis
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description of necrotizing external otitis: patients, profile of the bacterium, medical and chirurgical treatment, rate
2 secondary outcomes
Rate of Treatment Failure
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Duration of antibiotics
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Tristan Ferry, Md, PhD principal investigator
Hospices Civils de Lyon
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 Bone and Joint Infection, run by Hospices Civils de Lyon 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 1 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: finished, as of the sponsor's last update on 11 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of necrotizing external otitis (time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption). 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 11 Dec 2018.