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Invasive Markers of Staphylococcus Epidermidis

Identification of Genomic Markers Associated With the Invasiveness of Staphylococcus Epidermidis Strains Responsible for Infections

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03374371
Acronym
SepiNGS
Enrollment
320
Registered
2017-12-15
Start date
2018-03-01
Completion date
2020-12-18
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus Epidermidis Positive Blood Culture

Keywords

Staphylococcus epidermidis Infection, Staphylococcus epidermidis Contamination, intravascular device, implanted material

Brief summary

The purpose of the study is to identify biomarkers allowing the distinction between invasive and non-invasive strains of Staphylococcus epidermidis. This distinction is important to determine if the patient is infected and, as a consequence, if an antibiotic treatment is required.

Detailed description

In the hospital, a large proportion of bacteraemia and implantable medical device infections are caused by Staphylococcus epidermidis. This microorganism is the most abundant on human skin and all patients are carriers. Its remarkable ability to form biofilms on most materials explains that catheter-related infections are by far the most common. S. epidermidis infections are difficult to treat because most strains are multi-resistant and antibiotics are less effective in the presence of biofilms. In addition, S. epidermidis poses a major diagnostic problem because it is also the first source of contamination of blood culture sample and intraoperative samples (in case of suspected infection of orthopedic material in particular). Thus, when a sample is positive for S. epidermidis, there is less than a 25% chance that it reflects true bacteremia in the patient and 30% of patients would inappropriately receive vancomycin following contaminated blood cultures. Differentiating a contamination of a blood or intraoperative sample from true S. epidermidis infection is therefore crucial for patient management because unnecessary antibiotic therapy is potentially responsible for the emergence of resistant strains, toxicity and additional costs. The objective of this study is to identify the genetic markers that make it possible to differentiate the strains causing infections from the strains causing contamination by comparing their genomes using high throughput sequencing.

Interventions

technique of high-throughput sequencing of the markers present in the genome of the S. epidermidis strains responsible for infection in order to help to discriminate the true infections of the contaminations

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

CASE Inclusion Criteria: Population 1: nosocomial bacteraemia associated with intravascular devices 1. Hospitalized patient with intravascular device (peripheral or central, venous or arterial, short or long duration) for at least 48 hours before the development of bacteraemia 2. Presenting a definite infection with S. epidermidis according to the categorization criteria, Sub-Population 1A: 3a) Aged less than 28 days (New-born) Sub-population 1B: 3b) Aged 28 days or more Population 2: nosocomial infections of implanted material 1. An operated patient carrying implanted equipment following orthopaedic surgery, following cardiac surgery or following neurosurgery, 2. Presenting a definite infection with S. epidermidis according to the categorization criteria occurring in the year following surgery CONTROL Inclusion Criteria: Population 1: carrier of intravascular devices 1. Hospitalized patient with intravascular device (peripheral or central, venous or arterial, short or long duration) for at least 48 hours before positive blood culture with S. epidermidis 2. Certain contamination with S. epidermidis according to the categorization criteria, Sub-Population 1A: 3a) Aged less than 28 days (Newborn) Sub-population 1B: 3b) Aged 28 days or more Population 2: carrier of implanted material 1. An operated patient carrying implanted equipment following orthopedic surgery, following cardiac surgery or following neurosurgery, 2. Presenting a certain contamination to S. epidermidis according to the categorization criteria occurring in the year following surgery

Exclusion criteria

CASE

Design outcomes

Primary

MeasureTime frameDescription
genetic markers of S. epidermidisat the time of the positive sampling of S. epidermidisto identify genetic markers associated with a significant risk of invasive S. epidermidis infections

Secondary

MeasureTime frameDescription
Correlation of the genotype with the characteristics of the infectionsat the time of the positive sampling of S. epidermidisidentification of genetic markers specifically associated with a type of infection (catheter-related bacteremia in newborns, catheter-related bacteremia in patients 28 days or older, infections of orthopedic equipment or infections of cardiac equipment)
Intra-hospital cross-transmission detectionat the time of the positive sampling of S. EpidermidisThe comparison of the strains will be based on the study of the variations in the part of the genome that is common to all the strains to detect possible transfers between patients

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026