Improving Outcomes of Necrotising Otitis Externa
IONOE
A Multicentre Prospective Study to Improve Outcomes of Necrotising Otitis Externa in the UK
1 other identifier
observational
356
1 country
1
Brief Summary
A UK multi-centre prospective observational study of clinically possible cases of NOE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2021
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedStudy Start
First participant enrolled
August 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2024
CompletedMarch 19, 2024
March 1, 2024
3.3 years
June 25, 2021
March 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Risk Factors for NOE
12 months
Antibiotic Management of NOE
12 months
Role of Surgical Management in NOE
12 months
Economic Costs of NOE
12 months
Affect of NOE on Generic Health Status
12 months
- +2 more secondary outcomes
Study Arms (1)
Participants
Adults undergoing a CT scan to investigate possible NOE.
Interventions
Eligibility Criteria
Patients will be consented prior to or after CT imaging for a diagnosis of clinically possible NOE.
You may qualify if:
- 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.
You may not qualify if:
- Any previous clinical diagnosis of NOE.
- CT performed or due to be performed at hospital other than recruiting study site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne Hodgson, PhD
University of Oxford
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2021
First Posted
July 6, 2021
Study Start
August 20, 2021
Primary Completion
November 20, 2024
Study Completion
November 20, 2024
Last Updated
March 19, 2024
Record last verified: 2024-03