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

Bone and Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768635
• Other study ID #: 18-284
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: July 31, 2018

Study information

• Verified date: December 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 31, 2018
• Est. primary completion date: January 31, 2018
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Infection
• Otitis
• Otitis Externa

Intervention

Other:
• necrotizing external otitis
description of necrotizing external otitis

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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