Hôpital Necker Enfants Malades
Paris, Île-de-France Region, 75015, France
NCT Number: NCT03374371
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.
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Observational
Paris, Île-de-France Region, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
CASE Inclusion Criteria:
Population 1: nosocomial bacteraemia associated with intravascular devices
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
CONTROL Inclusion Criteria:
Population 1: carrier of intravascular devices
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
Exclusion criteria
CASE Exclusion Criteria Population 1: nosocomial bacteremia associated with intravascular devices
Population 2: nosocomial infections of implanted material
CONTROL Exclusion Criteria
Populations 1 and 2:
Opposition of the patient or the holders of parental authority (minor patients)
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
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
Time frame: at the time of the positive sampling of S. epidermidis
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)
Time frame: at the time of the positive sampling of S. Epidermidis
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
Assistance Publique - Hôpitaux de Paris
Other
Identification of Genomic Markers Associated With the Invasiveness of Staphylococcus Epidermidis Strains Responsible for Infections
Acronym: SepiNGS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.