An observational study in Necrotising Otitis Externa, sponsored by University of Oxford. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by University of Oxford · Observational
A UK multi-centre prospective observational study of clinically possible cases of NOE.
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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's enrollment of 356 is above the median of 300 across 685 observational studies indexed under Infections.
Browse Infections studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be consented prior to or after CT imaging for a diagnosis of clinically possible NOE.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adults undergoing a CT scan to investigate possible NOE.
Other: Observational Study
Observational study
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.
Time frame: 12 months
Risk Factors for NOE
Identify risk factors for clinically possible NOE, SOE and definite NOE in the UK
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Economic Costs of NOE
Investigate the economic impact of clinically possible NOE in UK as measured by hospital bed days.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Pseudomonas Aeruginosa
Genotypic and phenotypic analysis of P. aeruginosa isolates to assess relationship between virulence markers and disease severity.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2021 (actual). Primary completion is estimated for Nov 2024, 39 months after the start.
Of 257 non-industry observational studies under Infections, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 39 months is close to that.
Counting every sponsor, half of 295 studies reached it within 35 months; a quarter within 18 and three quarters within 67.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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