Staphylococcus Lugdunensis Prosthetic Joint Infection

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT04409392
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 43.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Staphylococcal Infections; Prosthetic Joint Infection	Other: Prothestic joint infection due to Staphylococcus lugdunensis

Study Design

• Study Type: Observational
• Actual Enrollment: 84 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study
• Actual Study Start Date: Feb 1, 2021
• Actual Primary Completion Date: Apr 1, 2021
• Actual Study Completion Date: Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; description of prosthetic joint infection with Staphylococcus lugdunensis

Outcome Measures

Primary Outcome Measures

1. Rate of PJI infection with Staphylococcus lugdunensis [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon	Lyon		France	69004

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04409392
• Other Study ID Numbers: 20-202
• First Posted: Jun 1, 2020
• Last Update Posted: Jun 16, 2021
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: Staphylococcus lugdunensis; Prosthetic Joint Infection; biofilm
• Additional relevant MeSH terms: Infections; Communicable Diseases; Arthritis, Infectious; Staphylococcal Infections

Study Results

No Results Posted as of Jun 16, 2021