Staphylococcus Epidermidis Positive Blood CultureSepiNGSNCT03374371
Invasive Markers of Staphylococcus Epidermidis
An observational study of Staphylococcus Epidermidis Positive Blood Culture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staphylococcus Epidermidis Positive Blood Culture
- What is being tested?
- high-throughput sequencing
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 18 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population 1 (bacteraemia related to intravascular devices) : patients hospitalized for at least 48 hours including new-borns Population 2 (infections of materials) : patients carrying medical devices implanted following an act of surgery (orthopedic, cardiac or neurosurgery)
Who may be able to join
- CASE Inclusion Criteria:
- Population 1: nosocomial bacteraemia associated with intravascular devices
- 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
- Presenting a definite infection with S. epidermidis according to the categorization criteria,
- Sub-Population 1A:
- 3a) Aged less than 28 days (New-born)
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- Sub-population 1B:
- 3b) Aged 28 days or more
- Population 2: nosocomial infections of implanted material
- An operated patient carrying implanted equipment following orthopaedic surgery, following cardiac surgery or following neurosurgery,
- 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
- 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
- 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
- An operated patient carrying implanted equipment following orthopedic surgery, following cardiac surgery or following neurosurgery,
- Presenting a certain contamination to S. epidermidis according to the categorization criteria occurring in the year following surgery
Who cannot join
- CASE Exclusion Criteria Population 1: nosocomial bacteremia associated with intravascular devices
- Opposition of the patient or the holders of parental authority (minor patients)
- Patient with polymicrobial infection
- Patient with a colonized catheter (positive catheter end culture <103UFC / mL) with no clinical signs of local or general infection and with sterile peripheral blood cultures
- Patient with local catheter infection (positive catheter end culture> 103UFC / mL) with local inflammatory signs only and with sterile peripheral blood cultures
- Population 2: nosocomial infections of implanted material
Show all 11Show fewer
- Opposition of the patient or the holders of parental authority (minor patients)
- Patient with an infection of material concomitant with a catheter-related infection
- CONTROL Exclusion Criteria
- Populations 1 and 2:
- Opposition of the patient or the holders of parental authority (minor patients)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Genomic Markers Associated With the Invasiveness of Staphylococcus Epidermidis Strains Responsible for Infections
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.
Read the 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.
- 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.
- Being tested
- high-throughput sequencing
- Keywords
- Staphylococcus epidermidis Infection, Staphylococcus epidermidis Contamination, intravascular device, implanted material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-throughput sequencingDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| S. epidermidis Infection (CASE) | Patients with confirmed infection at S. epidermidis Receives: Diagnostic Test: high-throughput sequencing | |
| S. epidermidis Contamination (CONTROL) | Patients with confirmed contamination at S. epidermidis Receives: Diagnostic Test: high-throughput sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic markers of S. epidermidis
to identify genetic markers associated with a significant risk of invasive S. epidermidis infections
Measured: at the time of the positive sampling of S. epidermidis
Secondary outcomes (2)
Correlation of the genotype with the characteristics of the infections
identification 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)
Measured: at the time of the positive sampling of S. epidermidis
Intra-hospital cross-transmission detection
The 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
Measured: at the time of the positive sampling of S. Epidermidis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Mar 2018
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus Epidermidis Positive Blood CultureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Anne JAMET, MD, Principal investigator, Assistance Public Hôpitaux de Paris (APHP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374371
- Sponsor's protocol ID
- NI17029J
- Other IDs
- 2017-A02742-51
- Acronym
- SepiNGS
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2017
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jamet A, Guglielmini J, Brancotte B, Coureuil M, Euphrasie D, Meyer J, Roux J, Barnier JP, Bille E, Ferroni A, Magny JF, Bole-Feysot C, Charbit A, Nassif X, Brisse S. High-Resolution Typing of Staphylococcus epidermidis Based on Core Genome Multilocus Sequence Typing To Investigate the Hospital Spread of Multidrug-Resistant Clones. J Clin Microbiol. 2021 Feb 18;59(3):e02454-20. doi: 10.1128/JCM.02454-20. Print 2021 Feb 18.
PubMed 33328176
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genomic Markers Associated With the Invasiveness of Staphylococcus Epidermidis Strains Responsible for Infections
- ClinicalTrials.gov ID
- NCT03374371
- Acronym / sponsor ID
- SepiNGS / NI17029J
- Keywords
- Staphylococcus epidermidis Infection, Staphylococcus epidermidis Contamination, intravascular device, implanted material
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 15 Dec 2017 (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.
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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S. epidermidis Infection (CASE) | – | Diagnostic Test: high-throughput sequencingPatients with confirmed infection at S. epidermidis |
| S. epidermidis Contamination (CONTROL) | – | Diagnostic Test: high-throughput sequencingPatients with confirmed contamination at S. epidermidis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population 1 (bacteraemia related to intravascular devices) : patients hospitalized for at least 48 hours including new-borns Population 2 (infections of materials) : patients carrying medical devices implanted following an act of surgery (orthopedic, cardiac or neurosurgery)
Key inclusion criteria (22 listed)
- Population 1: nosocomial bacteraemia associated with intravascular devices
- 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
- Presenting a definite infection with S. epidermidis according to the categorization criteria,
- 3a) Aged less than 28 days (New-born)
- 3b) Aged 28 days or more
Key exclusion criteria (11 listed)
- CASE Exclusion Criteria Population 1: nosocomial bacteremia associated with intravascular devices
- Opposition of the patient or the holders of parental authority (minor patients)
- Patient with polymicrobial infection
- Patient with a colonized catheter (positive catheter end culture <103UFC / mL) with no clinical signs of local or general infection and with sterile peripheral blood cultures
- Patient with local catheter infection (positive catheter end culture> 103UFC / mL) with local inflammatory signs only and with sterile peripheral blood cultures
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 |
|---|---|---|
| high-throughput sequencingtechnique 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 | Diagnostic test | S. epidermidis Contamination (CONTROL), S. epidermidis Infection (CASE) |
Primary outcome
genetic markers of S. epidermidis
Time frame: at the time of the positive sampling of S. epidermidis
to identify genetic markers associated with a significant risk of invasive S. epidermidis infections
2 secondary outcomes
Correlation of the genotype with the characteristics of the infections
Time frame: at the time of the positive sampling of S. epidermidis
Intra-hospital cross-transmission detection
Time frame: at the time of the positive sampling of S. Epidermidis
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 15 Jan 2026.
- Results publication: PubMed 33328176Jamet A, Guglielmini J, Brancotte B, Coureuil M, Euphrasie D, Meyer J, Roux J, Barnier JP, Bille E, Ferroni A, Magny JF, Bole-Feysot C, Charbit A, Nassif X, Brisse S. High-Resolution Typing of Staphylococcus epidermidis Based on Core Genome Multilocus Sequence Typing To Investigate the Hospital Spread of Multidrug-Resistant Clones. J Clin Microbiol. 2021 Feb 18;59(3):e02454-20. doi: 10.1128/JCM.02454-20. Print 2021 Feb 18.
- Individual participant dataSharing planned: No
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.
Anne JAMET, MD principal investigator
Assistance Public Hôpitaux de Paris (APHP)
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 Staphylococcus Epidermidis Positive Blood Culture, run by Assistance Publique - Hôpitaux de Paris 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 22 inclusion and 11 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 15 Jan 2026. 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?
genetic markers of S. epidermidis (time frame: at the time of the positive sampling of S. epidermidis). 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 NCT03374371, which also lists 1 linked publication.
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 15 Jan 2026.