Staphylococcus Lugdunensis Prosthetic Joint Infection

June 15, 2021 updated by: Hospices Civils de Lyon

Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lyon, France, 69004
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients having had IPA due to Staphylococcus lugdunensis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prothestic joint infection due to Staphylococcus lugdunensis
Patients having had a prosthetic joint infection with Staphylococcus lugdunensis
description of prosthetic joint infection with Staphylococcus lugdunensis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of PJI infection with Staphylococcus lugdunensis
Time Frame: between 2010 and 2020
proportion of patients having PJI infection with Staphylococcus lugdunensis, alone or with other bacteria
between 2010 and 2020
Description of PJI infection with Staphylococcus lugdunensis : type
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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
Description of PJI infection with Staphylococcus lugdunensis : evolution
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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
Description of patients with PJI infection due to Staphylococcus lugdunensis
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
type of patients: age, CMI
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Description of patients with PJI infection due to Staphylococcus lugdunensis : follow up
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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
Description of patients with PJI infection due to Staphylococcus lugdunensis : medical treatment
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description and duration of antibiotics
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Description of patients with PJI infection due to Staphylococcus lugdunensis : surgical treatment
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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
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
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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