Staphylococcus LugdunensisVISLISINCT02026895
Virulence of Staphylococcus Lugdunensis in Severe Infections
A study testing Genetic blood sample in people with Staphylococcus Lugdunensis and Bacteremia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The main objective is to identify new virulence factors produced by Staphylococcus lugdunensis that can be associated with clinical sign of severe infections and identified symptoms. The methodological approach is based on the comparison between the production of toxins by a given S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Lugdunensis, Bacteremia, Endocarditis
- What is being tested?
- Genetic blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Feb 2016
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 or more
- Signed informed consent form
- Proved infection by Staphylococcus lugdunensis: bacteremia, urine tract infection, endocarditis, bone and joint infections, skin and soft tissue infection, deep infection.
Who cannot join
- Age under 18
- Pregnancy or breastfeeding
- Contamination by Staphylococcus lugdunensis
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to identify new virulence factors produced by Staphylococcus lugdunensis that can be associated with clinical sign of severe infections and identified symptoms. The methodological approach is based on the comparison between the production of toxins by a given S. lugdunensis isolate classified in patients groups according to the infection clinically defined. Each group will be compared to the presence or not of studied virulence factors. Clinical features associated with toxin activity are not known for S. lugdunensis. This comparative approach is based on the hypotheses that drove to the definition of patient groups and their clinical criteria. However, in the absence of the evident correlation between production of toxins and kind of infection, the statistical evaluation will be completed by a multi-varied analysis. This approach has not been choosen first because of the multiple parameters that undergo during infection that may reveal relationships without true correlation. About the number of included patients in each defined group, if one of them does not reach the expected count, we still might extend inclusions to 3-6 months more. The presence of severe infections without usually defined risk is intriguing. For these last patients, we have planned, after their individual consent to achieve an exome sequencing. The obtained data will be compared to available resources for the human genome. By filtering data through usual protocols, we hope to able to focus onto few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due to S. lugdunensis without defined risk.
- Being tested
- Genetic blood sample
- Medical subject headings
- Bacteremia, Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic blood sampleGenetic
| Study group | Role | What they receive |
|---|---|---|
| Patient with infection by Staphylococcus lugdunensis | Experimental | Not described Receives: Genetic: Genetic blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of virulence factors
Several groups will be compared considering the presence/absence of virulence factors:
Bacteriemic VS non bacteriemic, Deep infection VS Skin/mucosal infection, Foreign body infection VS not, Presence of abscess VS not, Sepsis VS no sepsis, Septic embolism VS not, Portal of entry or not
The following virulence factors will be searched for:
TSST-1, enterotoxins, leukotoxins, epidermolysins, beta-hemolysins, SCIN-CHIPS, Sbi, Efb, SdrE
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes (3)
Clinical characteristics of infections
Characteristics of infection: comorbidities (Charlson score) - history of the disease - clinical, cytological , immunological, inflammatory and organ functions parameters - results of additional tests conducted under their care - response to treatment - morbidity and mortality
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Whole human transcriptome analysis for selected patients
Measured: Genetic blood samples will be analyzed together after the end of inclusion period (18 months)
Genome sequencing of selected strains of Staphylococcus lugdunensis
Measured: Genetic blood samples will be analyzed together after the end of inclusion period (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus LugdunensisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves HANSMANN, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026895
- Sponsor's protocol ID
- 5616
- Acronym
- VISLISI
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2013
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Argemi X, Martin V, Loux V, Dahyot S, Lebeurre J, Guffroy A, Martin M, Velay A, Keller D, Riegel P, Hansmann Y, Paul N, Prevost G. Whole-Genome Sequencing of Seven Strains of Staphylococcus lugdunensis Allows Identification of Mobile Genetic Elements. Genome Biol Evol. 2017 May 1;9(5). doi: 10.1093/gbe/evx077.
PubMed 28444231Argemi X, Prevost G, Riegel P, Provot C, Badel-Berchoux S, Jehl F, Olivares E, Hansmann Y. Kinetics of biofilm formation by Staphylococcus lugdunensis strains in bone and joint infections. Diagn Microbiol Infect Dis. 2017 Aug;88(4):298-304. doi: 10.1016/j.diagmicrobio.2017.05.002. Epub 2017 May 12.
PubMed 28529089Argemi X, Matelska D, Ginalski K, Riegel P, Hansmann Y, Bloom J, Pestel-Caron M, Dahyot S, Lebeurre J, Prevost G. Comparative genomic analysis of Staphylococcus lugdunensis shows a closed pan-genome and multiple barriers to horizontal gene transfer. BMC Genomics. 2018 Aug 20;19(1):621. doi: 10.1186/s12864-018-4978-1.
PubMed 30126366Argemi X, Hansmann Y, Prola K, Prevost G. Coagulase-Negative Staphylococci Pathogenomics. Int J Mol Sci. 2019 Mar 11;20(5):1215. doi: 10.3390/ijms20051215.
PubMed 30862021
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virulence of Staphylococcus Lugdunensis in Severe Infections
- ClinicalTrials.gov ID
- NCT02026895
- Acronym / sponsor ID
- VISLISI / 5616
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Jan 2014 (estimated)
- 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.
The main objective is to identify new virulence factors produced by Staphylococcus lugdunensis that can be associated with clinical sign of severe infections and identified symptoms. The methodological approach is based on the comparison between the production of toxins by a given S. lugdunensis isolate classified in patients groups according to the infection clinically defined. Each group will be compared to the presence or not of studied virulence factors. Clinical features associated with toxin activity are not known for S. lugdunensis. This comparative approach is based on the hypotheses that drove to the definition of patient groups and their clinical criteria. However, in the absence of the evident correlation between production of toxins and kind of infection, the statistical evaluation will be completed by a multi-varied analysis. This approach has not been choosen first because of the multiple parameters that undergo during infection that may reveal relationships without true correlation. About the number of included patients in each defined group, if one of them does not reach the expected count, we still might extend inclusions to 3-6 months more. The presence of severe infections without usually defined risk is intriguing. For these last patients, we have planned, after their individual consent to achieve an exome sequencing. The obtained data will be compared to available resources for the human genome. By filtering data through usual protocols, we hope to able to focus onto few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due to S. lugdunensis without defined risk.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with infection by Staphylococcus lugdunensis | Experimental | Genetic: Genetic blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or more
- Signed informed consent form
- Proved infection by Staphylococcus lugdunensis: bacteremia, urine tract infection, endocarditis, bone and joint infections, skin and soft tissue infection, deep infection.
Key exclusion criteria (3 listed)
- Age under 18
- Pregnancy or breastfeeding
- Contamination by Staphylococcus lugdunensis
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 |
|---|---|---|
| Genetic blood sample | Genetic | Patient with infection by Staphylococcus lugdunensis |
Primary outcome
Presence/absence of virulence factors
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Several groups will be compared considering the presence/absence of virulence factors: Bacteriemic VS non bacteriemic, Deep infection VS Skin/mucosal infection, Foreign body infection VS not, Presence of abscess VS not, Sepsis VS no sepsis, Septic embolism VS not, Portal of entry or not The following virulence factors will be searched for: TSST-1, enterotoxins, leukotoxins, epidermolysins, beta-hemolysins, SCIN-CHIPS, Sbi, Efb, SdrE
3 secondary outcomes
Clinical characteristics of infections
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Whole human transcriptome analysis for selected patients
Time frame: Genetic blood samples will be analyzed together after the end of inclusion period (18 months)
Genome sequencing of selected strains of Staphylococcus lugdunensis
Time frame: Genetic blood samples will be analyzed together after the end of inclusion period (18 months)
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 22 Dec 2025.
- Results publication: PubMed 28444231Argemi X, Martin V, Loux V, Dahyot S, Lebeurre J, Guffroy A, Martin M, Velay A, Keller D, Riegel P, Hansmann Y, Paul N, Prevost G. Whole-Genome Sequencing of Seven Strains of Staphylococcus lugdunensis Allows Identification of Mobile Genetic Elements. Genome Biol Evol. 2017 May 1;9(5). doi: 10.1093/gbe/evx077.
- Results publication: PubMed 28529089Argemi X, Prevost G, Riegel P, Provot C, Badel-Berchoux S, Jehl F, Olivares E, Hansmann Y. Kinetics of biofilm formation by Staphylococcus lugdunensis strains in bone and joint infections. Diagn Microbiol Infect Dis. 2017 Aug;88(4):298-304. doi: 10.1016/j.diagmicrobio.2017.05.002. Epub 2017 May 12.
- Results publication: PubMed 30126366Argemi X, Matelska D, Ginalski K, Riegel P, Hansmann Y, Bloom J, Pestel-Caron M, Dahyot S, Lebeurre J, Prevost G. Comparative genomic analysis of Staphylococcus lugdunensis shows a closed pan-genome and multiple barriers to horizontal gene transfer. BMC Genomics. 2018 Aug 20;19(1):621. doi: 10.1186/s12864-018-4978-1.
- Results publication: PubMed 30862021Argemi X, Hansmann Y, Prola K, Prevost G. Coagulase-Negative Staphylococci Pathogenomics. Int J Mol Sci. 2019 Mar 11;20(5):1215. doi: 10.3390/ijms20051215.
Related trials for Staphylococcus Lugdunensis
Not yet recruitingPhase 1/2
Bacteriophage Therapy for Staphylococcus Lugdunensis Prosthetic Joint Infection
Prosthetic Joint Infections of Hip, Bacteriophage Therapy
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.
Yves HANSMANN, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic blood sample in people with Staphylococcus Lugdunensis and Bacteremia, run by University Hospital, Strasbourg, France 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 3 inclusion and 3 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 22 Dec 2025. 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?
Presence/absence of virulence factors (time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02026895, which also lists 4 linked publications.
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 22 Dec 2025.