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Virulence of Staphylococcus Lugdunensis in Severe Infections

NCT ID: NCT02026895

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Staphylococcus Lugdunensis Bacteremia Endocarditis Virulence Factors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patient with infection by Staphylococcus lugdunensis

Group Type EXPERIMENTAL

Genetic blood sample

Intervention Type GENETIC

Interventions

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Genetic blood sample

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Age under 18
* Pregnancy or breastfeeding
* Contamination by Staphylococcus lugdunensis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves HANSMANN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

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University Hospital

Strasbourg, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 28444231 (View on PubMed)

Argemi 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.

Reference Type RESULT
PMID: 28529089 (View on PubMed)

Argemi 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.

Reference Type RESULT
PMID: 30126366 (View on PubMed)

Argemi 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.

Reference Type RESULT
PMID: 30862021 (View on PubMed)

Other Identifiers

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5616

Identifier Type: -

Identifier Source: org_study_id