Prospective Study of Staphylococcus Aureus Clinical Isolates Versus Colonization: RNAs as Potential Biomarkers for Bloodstream Infections

NCT03833102 | Completed

• 1 other identifier: 35RC17_9726_PROSAC
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to demonstrate that the risk of S. aureus bacteremia (SAB) is correlated to the RNA III and SprD RNAs expression

Conditions

Staphylococcus Aureus

Keywords

Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• Levels of RNAIII expression and sprD in isolated strains of S. aureus from bacteremia

  Levels of expression of RNAIII and sprD in isolated strains of S. aureus isolated from bacteremia, compared to these same levels of expression in strains from colonized, uninfected patients.

  through study completion, an average of 1 year

Study Arms (2)

Colonized patients' group (CPG)

all adult patients hospitalized in or consulting the Rennes University Hospital, known as S. aureus colonized could be included. In our institution, S. aureus colonization in the nostrils is screened in all patients supposed to undergo neurosurgical or orthopedic surgery.

Other: biological analysis

SAB patients' group (SAB)

all adult patients with SAB could be included. S. aureus colonization in the nostrils will be systematically screened immediately after the first result of positive S. aureus blood culture. Two subgroups will be individualized depending on the SOFA Score: * Severe patients * Non-severe patients

Other: biological analysis

Interventions

biological analysis OTHER

ST types will be determined for all individualized bacterial strains. For all the bacterial strains, RNAs expression will be analyzed at three different growth phases: early exponential phase, mid exponential phase and early stationary phase. Expression of RNAIII and SprD will be evaluated by quantitative polymerase chain reaction.

Colonized patients' group (CPG); SAB patients' group (SAB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patients hospitalized S. aureus colonized or with SAB

You may qualify if:

• Patient over 18 years of age;
• Patients hospitalized at the University Hospital of Rennes, with according to groups:
• : Colonized subjects:
• Any patient hospitalized at the University Hospital of Rennes, or any health professional, in whom a colonization screening with S. aureus is performed in routine care and a colonization with S. aureus is documented;
• (For information, this screening is carried out frequently at the University Hospital of Rennes for different reasons (before surgery or procedure requiring the installation of equipment, screening of contact cases of infected cases, investigation during a nosocomial epidemic...). These people are hospitalized for reasons other than S. aureus infection and in different departments, but the samples are collected centrally in the institution's bacteriology laboratory.)
• : Patients hospitalized for BSA:
• Patients hospitalized in the infectious diseases and medical intensive care unit and in the surgical intensive care unit, for whom a BSA is documented at the bacteriology laboratory of the University Hospital of Rennes;
• Patients for whom nasal carrying screening for S. aureus is prescribed as part of their management;
• These patients will be classified into two groups:
• Serious clinic (CG):
• BSA ;
• Associated with signs of sepsis according to the 20168 international definition:
• SOFA score (see Appendix 3) 2 ;
• Septic shock will be defined as the existence of sepsis associated with persistent low blood pressure requiring the administration of vasopressors to obtain an average blood pressure (MAP) 65 mmHg and an arterial lactate dosage 2 mmol/L despite adequate vascular filling.
• \) Non-serious clinic (CNG):

You may not qualify if:

• Pregnant or breastfeeding women;
• Persons of full age who are subject to legal protection (protection of justice, guardianship, guardianship), persons deprived of their liberty;
• S. aureus strain producing leucocidin from Panton-Valentine;

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

isolates from patients' blood or nostrils

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Biological Oxygen Demand Analysis

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Matthieu REVEST

  Centre Hospitalier Universitairede Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 6, 2019
• Study Start: February 21, 2018
• Primary Completion: November 22, 2022
• Study Completion: February 22, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

FR (1)