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Trial record 1 of 1 for:    IONOE
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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
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
A UK multi-centre prospective observational study of clinically possible cases of NOE.

Condition or disease Intervention/treatment
Necrotising Otitis Externa 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 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.

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Study Type : Observational
Estimated Enrollment : 820 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Risk Factors for NOE [ Time Frame: 12 months ]
    Identify risk factors for clinically possible NOE, SOE and definite NOE in the UK

  2. 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.

  3. 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.

  4. Economic Costs of NOE [ Time Frame: 12 months ]
    Investigate the economic impact of clinically possible NOE in UK as measured by hospital bed days.

  5. 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.

  6. 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.

  7. 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
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Michelle Kumin, PhD +44 (0)7527617768 michelle.kumin@ndm.ox.ac.uk

Locations
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United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Michelle Kumin, PhD    +44 (0)7527617768    michelle.kumin@ndm.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Susanne Hodgson, PhD University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04950985    
Other Study ID Numbers: IRAS:280342
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
infection
antimicrobials
otitis
externa
Additional relevant MeSH terms:
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Otitis
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases