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Necrotizing External Otitis : Study in a Regional Bone and Joint Infection Reference Center

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ClinicalTrials.gov Identifier: NCT03768635
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Eugénie MABRUT, Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Bone and Joint Infection Other: necrotizing external otitis

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Necrotizing External Otitis : Study in a Regional Bone and Joint Infection
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : July 31, 2018

Group/Cohort Intervention/treatment
Necrotizing external otitis
description of necrotizing external otitis
Other: necrotizing external otitis
description of necrotizing external otitis




Primary Outcome Measures :
  1. Rate of necrotizing external otitis [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    description of necrotizing external otitis: patients, profile of the bacterium, medical and chirurgical treatment, rate


Secondary Outcome Measures :
  1. Rate of Treatment Failure [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor.

  2. Duration of antibiotics [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    Description of the strategies of antibiotic treatments used (double-agent therapy, monotherapy, duration)



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

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): NCT03768635


Locations
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France
Hospices Civils de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Tristan Ferry, Md, PhD Hospices Civils de Lyon

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Responsible Party: Eugénie MABRUT, Clinical Reseacrh Assistant, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03768635     History of Changes
Other Study ID Numbers: 18-284
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
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 Eugénie MABRUT, Hospices Civils de Lyon:
otitis

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Otitis
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases