Implant-Associated P. Aeruginosa Bone And Joint Infections : Experience In A Regional Reference Center In France

Bone and Joint Infection Clinical Trial

Official title:

Implant-Associated P. Aeruginosa Bone And Joint Infections : Experience In A Regional Reference Center In France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624855
• Other study ID #: 18-176
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: May 1, 2018

Study information

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

Clinical Trial Summary

The aim of this study is to describe the bone or joint infection due to Pseudomonas aeruginosa in patients having implant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• patients having BJI on implant caused by Pseudomonas aeruginosa

Exclusion Criteria:

Related Conditions & MeSH terms

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

Intervention

Other:
• Bone or joint infection due to Pseudomonas aeruginosa
Description of bone or joint infection on implant due to Pseudomonas aeruginosa

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	Description and rate of bone or joint infection on implant caused due to Pseudomonas aeruginosa	Description of the type of infection due to P. aeruginosa : patients and type of implant, 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 adverse events occurring under medical treatment against Pseudomonas aeruginosa	description of adverse events occurring under medical treatment against Pseudomonas aeruginosa in BJI	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	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)