Improving Outcomes of Necrotising Otitis Externa (IONOE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Necrotising Otitis Externa
• Intervention / Treatment: Other: Observational Study

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 Type: Observational
• Enrollment (Actual): 356

Contacts and Locations

• Study Contact: Name: Michelle Kumin, PhD; Phone Number: +44 (0)7527617768; Email: michelle.kumin@ndm.ox.ac.uk

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be consented prior to or after CT imaging for a diagnosis of clinically possible NOE.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Any previous clinical diagnosis of NOE.
• CT performed or due to be performed at hospital other than recruiting study site.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants; Adults undergoing a CT scan to investigate possible NOE.	Other: Observational Study; Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Factors for NOE	Identify risk factors for clinically possible NOE, SOE and definite NOE in the UK	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.	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.	12 months
Economic Costs of NOE	Investigate the economic impact of clinically possible NOE in UK as measured by hospital bed days.	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.	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.	12 months
Pseudomonas Aeruginosa	Genotypic and phenotypic analysis of P. aeruginosa isolates to assess relationship between virulence markers and disease severity.	12 months

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Susanne Hodgson, PhD, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Estimated): November 20, 2024
• Study Completion (Estimated): November 20, 2024

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: infection; otitis; antimicrobials; externa
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis Externa; Otitis
• Other Study ID Numbers: IRAS:280342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No