NCT03768635

Brief Summary

The malignant external otitis is a rare disease which arises more frequently at the elderly and the diabetics patients. To our knowledge, there are few data and it is not wellc known byclinicians. Nevertheless it exposes to neurological complications potentially serious and crippling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

12.1 years

First QC Date

December 5, 2018

Last Update Submit

December 7, 2018

Conditions

Bone and Joint Infection

Keywords

otitis

Outcome Measures

Primary Outcomes (1)

  • Rate of necrotizing external otitis

    description of necrotizing external otitis: patients, profile of the bacterium, medical and chirurgical treatment, rate

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Secondary Outcomes (2)

  • Rate of Treatment Failure

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

  • Duration of antibiotics

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Study Arms (1)

Necrotizing external otitis

description of necrotizing external otitis

Other: necrotizing external otitis

Interventions

necrotizing external otitisOTHER

description of necrotizing external otitis

Necrotizing external otitis

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center between 01/01/2006 and 31/01/2018

You may qualify if:

  • patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Otitis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Tristan Ferry, Md, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Reseacrh Assistant

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 7, 2018

Study Start

January 1, 2006

Primary Completion

January 31, 2018

Study Completion

July 31, 2018

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

FR(1)