Improving Outcomes of Necrotising Otitis Externa (IONOE)
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|ClinicalTrials.gov Identifier: NCT04950985|
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : September 30, 2021
|Condition or disease||Intervention/treatment|
|Necrotising Otitis Externa||Other: Observational Study|
Patients with clinically possible NOE for whom CT imaging is requested will be recruited to the study by hospital staff at 5-15 UK sites.
NOE remains a relatively uncommon condition with UK - ENT surgeons report seeing between 1 and 10 cases per year. Extrapolating from pilot data, it is anticipated that 820 eligible patients will be identified in 10 hospital sites over a 12-month recruitment period of which approximately 90 would be definite cases of NOE.
Patients will be 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 Type :||Observational|
|Estimated Enrollment :||820 participants|
|Official Title:||A Multicentre Prospective Study to Improve Outcomes of Necrotising Otitis Externa in the UK|
|Actual Study Start Date :||August 20, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Adults undergoing a CT scan to investigate possible NOE.
Other: Observational Study
- 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.
- Risk Factors for NOE [ Time Frame: 12 months ]Identify risk factors for clinically possible NOE, SOE and definite NOE in the UK
- Antibiotic Management of NOE [ Time Frame: 12 months ]Understand whether differences in antibiotic choice and duration impact on clinical outcome of patients with SOE or NOE in the UK.
- Role of Surgical Management in NOE [ Time Frame: 12 months ]Describe the role of superficial sampling of the EAC, deep surgical sampling and debridement in cases of clinically possible NOE in the UK.
- Economic Costs of NOE [ Time Frame: 12 months ]Investigate the economic impact of clinically possible NOE in UK as measured by hospital bed days.
- Affect of NOE on Generic Health Status [ Time Frame: 12 months ]Assess changes in generic health status as measured using EQ-5D-3L in the year following enrolment of clinically possible NOE cases.
- Radiological Changes of NOE [ Time Frame: 12 months ]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.
- Pseudomonas Aeruginosa [ Time Frame: 12 months ]Genotypic and phenotypic analysis of P. aeruginosa isolates to assess relationship between virulence markers and disease severity.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04950985
|Contact: Michelle Kumin, PhD||+44 (0)email@example.com|
|Oxford University Hospitals NHS Foundation Trust||Recruiting|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Contact: Michelle Kumin, PhD +44 (0)7527617768 firstname.lastname@example.org|
|Principal Investigator:||Susanne Hodgson, PhD||University of Oxford|