Status:
COMPLETED
Invasive Markers of Staphylococcus Epidermidis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Staphylococcus Epidermidis Positive Blood Culture
Eligibility:
All Genders
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 p...
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 pat...
Eligibility Criteria
Inclusion
- CASE
- 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)
- 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
- 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
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03374371
Start Date
March 1 2018
End Date
December 18 2020
Last Update
December 10 2021
Active Locations (1)
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1
Hôpital Necker Enfants Malades
Paris, Île-de-France Region, France, 75015