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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone and Joint Infection
• Intervention / Treatment: Other: necrotizing external otitis

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Tristan Ferry, Md, PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: otitis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Otorhinolaryngologic Diseases; Ear Diseases; Infections; Communicable Diseases; Arthritis, Infectious; Otitis Externa; Otitis
• Other Study ID Numbers: 18-284

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