Staphylococcal InfectionsNCT04409392
Staphylococcus Lugdunensis Prosthetic Joint Infection
An observational study of Staphylococcal Infections and Prosthetic Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Infections, Prosthetic Joint Infection
- What is being tested?
- Prothestic joint infection due to Staphylococcus lugdunensis
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients having had IPA due to Staphylococcus lugdunensis
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Prothestic joint infection due to Staphylococcus lugdunensis
- Keywords
- Staphylococcus lugdunensis, Prosthetic Joint Infection, biofilm
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prothestic joint infection due to Staphylococcus lugdunensisOther
description of prosthetic joint infection with Staphylococcus lugdunensis
| Study group | Role | What they receive |
|---|---|---|
| Prothestic joint infection due to Staphylococcus lugdunensis | Patients having had a prosthetic joint infection with Staphylococcus lugdunensis Receives: Other: Prothestic joint infection due to Staphylococcus lugdunensis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PJI infection with Staphylococcus lugdunensis
proportion of patients having PJI infection with Staphylococcus lugdunensis, alone or with other bacteria
Measured: between 2010 and 2020
Description of PJI infection with Staphylococcus lugdunensis : type
type of PJI : knee or hip prosthesis
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Feb 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409392
- Sponsor's protocol ID
- 20-202
- Status last verified
- Nov 2020
- First submitted
- 27 May 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04409392
- Acronym / sponsor ID
- 20-202
- Keywords
- Staphylococcus lugdunensis, Prosthetic Joint Infection, biofilm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prothestic joint infection due to Staphylococcus lugdunensis | – | Other: Prothestic joint infection due to Staphylococcus lugdunensisPatients having had a prosthetic joint infection with Staphylococcus lugdunensis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having had IPA due to Staphylococcus lugdunensis
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prothestic joint infection due to Staphylococcus lugdunensisdescription of prosthetic joint infection with Staphylococcus lugdunensis | Other | Prothestic joint infection due to Staphylococcus lugdunensis |
Primary outcome
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcal Infections and Prosthetic Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PJI infection with Staphylococcus lugdunensis (time frame: between 2010 and 2020). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021; AzTrials last refreshed its copy on 29 Oct 2026.