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NCT Number: NCT04409392

Staphylococcus Lugdunensis Prosthetic Joint Infection

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.

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Key information

Conditions

Staphylococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Prosthetic Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prothestic joint infection due to Staphylococcus lugdunensis

Other

description of prosthetic joint infection with Staphylococcus lugdunensis

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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