NCT04409392

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

June 16, 2021

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

May 27, 2020

Last Update Submit

June 15, 2021

Conditions

Staphylococcal InfectionsProsthetic Joint Infection

Keywords

Staphylococcus lugdunensisProsthetic Joint Infectionbiofilm

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Prothestic joint infection due to Staphylococcus lugdunensis

Patients having had a prosthetic joint infection with Staphylococcus lugdunensis

Other: Prothestic joint infection due to Staphylococcus lugdunensis

Interventions

Prothestic joint infection due to Staphylococcus lugdunensisOTHER

description of prosthetic joint infection with Staphylococcus lugdunensis

Prothestic joint infection due to Staphylococcus lugdunensis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having had IPA due to Staphylococcus lugdunensis

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Links

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 1, 2020

Study Start

February 1, 2021

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

June 16, 2021

Record last verified: 2020-11

Locations

FR(1)