Staphylococcus Lugdunensis Prosthetic Joint Infection

Prosthetic Joint Infection Clinical Trial

Official title:

Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409392
• Other study ID #: 20-202
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: November 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Staphylococcus lugdunensis is a coagulase-negative staphylococcus belonging to the human commensal cutaneous flora, and has been little studied in the field of prosthetic joint infections. However, it shares many virulence traits with Staphylococcus aureus, including many adhesins and its ability to form biofilm, and the few series of cases reports a significant failure rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• infection of joint prosthesis (whatever its type) with Staphylococcus lugdunensis defined by the positivity of at least 2 gold-standard samples (joint puncture, intraoperative samples) with S. lugdunensis; OR
• a single positive gold-standard sample or positive blood cultures AND formal clinical, radiological, biological and / or pathological arguments in favor of an infection of joint prosthesis AND absence of other pathogenic agent

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infection
• Prosthetic Joint Infection
• Staphylococcal Infections

Intervention

Other:
• Prothestic joint infection due to Staphylococcus lugdunensis
description of prosthetic joint infection with Staphylococcus lugdunensis

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 PJI infection with Staphylococcus lugdunensis	proportion of patients having PJI infection with Staphylococcus lugdunensis, alone or with other bacteria	between 2010 and 2020
Primary	Description of PJI infection with Staphylococcus lugdunensis : type	type of PJI : knee or hip prosthesis	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Primary	Description of PJI infection with Staphylococcus lugdunensis : evolution	evolution of PJI :evolution between prosthesis placement and the onset of symptoms, gateway to infection	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Primary	Description of patients with PJI infection due to Staphylococcus lugdunensis	type of patients: age, CMI	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Primary	Description of patients with PJI infection due to Staphylococcus lugdunensis : follow up	duration of the follow up of patients	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Primary	Description of patients with PJI infection due to Staphylococcus lugdunensis : medical treatment	description and duration of antibiotics	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Primary	Description of patients with PJI infection due to Staphylococcus lugdunensis : surgical treatment	description of surgery performed : DAIR, one-step exchange, two-step exchange	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Primary	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

External Links

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