Necrotising Otitis ExternaIONOENCT04950985
Improving Outcomes of Necrotising Otitis Externa
An observational study of Necrotising Otitis Externa, run by University of Oxford at 1 site in United Kingdom.
Trial summary
A UK multi-centre prospective observational study of clinically possible cases of NOE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotising Otitis Externa
- What is being tested?
- Observational Study
- How many people
- 356 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Aug 2021to 20 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be consented prior to or after CT imaging for a diagnosis of clinically possible NOE.
Who may be able to join
- Adult patients (≥ 18 years old).
- Clinical diagnosis of possible NOE for whom CT imaging is requested or has been done as part of routine clinical care.
Who cannot join
- Any previous clinical diagnosis of NOE.
- CT performed or due to be performed at hospital other than recruiting study site.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: A Multicentre Prospective Study to Improve Outcomes of Necrotising Otitis Externa in the UK
A UK multi-centre prospective observational study of clinically possible cases of NOE.
Read the detailed description
Patients with clinically possible NOE for whom CT imaging is requested will be recruited to the study by hospital staff at 20-25 UK sites.
NOE remains a relatively uncommon condition with UK - ENT surgeons report seeing between 1 and 10 cases per year. We plan to recruit 350 patients consented prior to or after CT imaging for a diagnosis of clinically possible NOE. After providing consent, patients will be asked to complete an EQ-5D-3L questionnaire. For patients consented remotely, this questionnaire will be completed via an interview. Local study staff will complete an online case report form hosted on Redcap™ for each patient including data on demographics, co-morbidities, clinical presentation, investigations and surgical and antibiotic management. Local study staff will review patients' hospital notes and contact patients' GPs by telephone 1-year post recruitment to assess clinical outcomes and mortality rates. Patients will then be contacted 12 months (+/- 1 month) post-recruitment by telephone by local study staff in order to confirm clinical outcomes (e.g. relapse) and gain information to complete the EQ-5D-3L questionnaire a second time.
All CT scans performed at recruitment and any other CT and/or MRI scans performed in the 12-month follow-up period will be de-identified and uploaded by local sites to an online, web-based secure repository for radiological images. Subspecialised radiologists blinded to clinical details will assess the images according to pre-agreed, standardised criteria.
Selected sites will be asked to freeze any P. aeruginosa isolates routinely collected via ear swabs as part of clinical care from enrolled participants within 14 days of CT imaging. These de-identified samples may be sent from sites to undergo genotypic and phenotypic analysis at the University of Oxford for virulence factors to assess the relationship between these and disease severity. Of note, no samples beyond those routinely collected as part of the patients' care will be collected and no patient tissue samples will be stored. These samples will not contain any biological or genetic material from the patient.
- Conditions
- Necrotising Otitis Externa
- Being tested
- Observational Study
- Keywords
- infection, antimicrobials, otitis, externa
- Medical subject headings
- Infections, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Participants | Adults undergoing a CT scan to investigate possible NOE. Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic, management and outcome data
Describe the prevalence, demographics, clinical presentation, surgical and medical management and outcomes of clinically possible cases of NOE in the UK.
Measured: 12 months
Secondary outcomes (7)
Risk Factors for NOE
Identify risk factors for clinically possible NOE, SOE and definite NOE in the UK
Measured: 12 months
Antibiotic Management of NOE
Understand whether differences in antibiotic choice and duration impact on clinical outcome of patients with SOE or NOE in the UK.
Measured: 12 months
Role of Surgical Management in NOE
Describe the role of superficial sampling of the EAC, deep surgical sampling and debridement in cases of clinically possible NOE in the UK.
Measured: 12 months
Economic Costs of NOE
Investigate the economic impact of clinically possible NOE in UK as measured by hospital bed days.
Measured: 12 months
Affect of NOE on Generic Health Status
Assess changes in generic health status as measured using EQ-5D-3L in the year following enrolment of clinically possible NOE cases.
Measured: 12 months
Radiological Changes of NOE
Assess agreement in interpretation of CT and/or MRI scans of clinically possible cases of NOE between locally reporting radiologists and blinded neuroradiology specialists working according to proposed standardised radiological criteria.
Measured: 12 months
Pseudomonas Aeruginosa
Genotypic and phenotypic analysis of P. aeruginosa isolates to assess relationship between virulence markers and disease severity.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start20 Aug 2021
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotising Otitis ExternaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Hodgson, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950985
- Sponsor's protocol ID
- IRAS:280342
- Acronym
- IONOE
- Status last verified
- Mar 2024
- First submitted
- 25 Jun 2021
- Last updated
- 19 Mar 2024
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Study to Improve Outcomes of Necrotising Otitis Externa in the UK
- ClinicalTrials.gov ID
- NCT04950985
- Acronym / sponsor ID
- IONOE / IRAS:280342
- Conditions
- Necrotising Otitis Externa
- Keywords
- infection, antimicrobials, otitis, externa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 6 Jul 2021 (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.
A UK multi-centre prospective observational study of clinically possible cases of NOE.
Detailed description
Patients with clinically possible NOE for whom CT imaging is requested will be recruited to the study by hospital staff at 20-25 UK sites.
NOE remains a relatively uncommon condition with UK - ENT surgeons report seeing between 1 and 10 cases per year. We plan to recruit 350 patients consented prior to or after CT imaging for a diagnosis of clinically possible NOE. After providing consent, patients will be asked to complete an EQ-5D-3L questionnaire. For patients consented remotely, this questionnaire will be completed via an interview. Local study staff will complete an online case report form hosted on Redcap™ for each patient including data on demographics, co-morbidities, clinical presentation, investigations and surgical and antibiotic management. Local study staff will review patients' hospital notes and contact patients' GPs by telephone 1-year post recruitment to assess clinical outcomes and mortality rates. Patients will then be contacted 12 months (+/- 1 month) post-recruitment by telephone by local study staff in order to confirm clinical outcomes (e.g. relapse) and gain information to complete the EQ-5D-3L questionnaire a second time.
All CT scans performed at recruitment and any other CT and/or MRI scans performed in the 12-month follow-up period will be de-identified and uploaded by local sites to an online, web-based secure repository for radiological images. Subspecialised radiologists blinded to clinical details will assess the images according to pre-agreed, standardised criteria.
Selected sites will be asked to freeze any P. aeruginosa isolates routinely collected via ear swabs as part of clinical care from enrolled participants within 14 days of CT imaging. These de-identified samples may be sent from sites to undergo genotypic and phenotypic analysis at the University of Oxford for virulence factors to assess the relationship between these and disease severity. Of note, no samples beyond those routinely collected as part of the patients' care will be collected and no patient tissue samples will be stored. These samples will not contain any biological or genetic material from the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Observational StudyAdults undergoing a CT scan to investigate possible NOE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be consented prior to or after CT imaging for a diagnosis of clinically possible NOE.
Key inclusion criteria (2 listed)
- Adult patients (≥ 18 years old).
- Clinical diagnosis of possible NOE for whom CT imaging is requested or has been done as part of routine clinical care.
Key exclusion criteria (2 listed)
- Any previous clinical diagnosis of NOE.
- CT performed or due to be performed at hospital other than recruiting study site.
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 |
|---|---|---|
| Observational StudyObservational study | Other | Participants |
Primary outcome
Demographic, management and outcome data
Time frame: 12 months
Describe the prevalence, demographics, clinical presentation, surgical and medical management and outcomes of clinically possible cases of NOE in the UK.
7 secondary outcomes
Risk Factors for NOE
Time frame: 12 months
Antibiotic Management of NOE
Time frame: 12 months
Role of Surgical Management in NOE
Time frame: 12 months
Economic Costs of NOE
Time frame: 12 months
Affect of NOE on Generic Health Status
Time frame: 12 months
Radiological Changes of NOE
Time frame: 12 months
Pseudomonas Aeruginosa
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Undecided
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.
Susanne Hodgson, PhD principal investigator
University of Oxford
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 Necrotising Otitis Externa, run by University of Oxford at 1 site in United Kingdom.
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 2 inclusion and 2 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 19 Mar 2024. 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 United Kingdom. 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?
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?
Demographic, management and outcome data (time frame: 12 months). 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 19 Mar 2024; AzTrials last refreshed its copy on 4 Nov 2026.