Role of the NLRP3 Inflammasome in Escherichia Coli and Staphylococcus Aureus Bacteria (NLRP3-Bact)

March 7, 2019 updated by: Centre Hospitalier Universitaire de Nice
Our previous studies delineate a novel pathway of immune activation in animals that the investigators have named Anti-Virulence Immunity (AVI). Using a mice model of bacteremia, the investigators have demonstrated that Escherichia coli Cytotoxic Necrotizing Factor 1 (CNF1) activity is sensed by the immune system. This immune sensing results in a rapid bacterial clearing during bacteremia triggered by uropathogenic E. coli-expressing CNF1. The investigators already confirmed the involvement of one inflammasome using macrophages isolated from Knock-out mice. The investigators have recently determined the conservation in human monocytes of the interleukin -1beta maturation triggered by CNF1 and observed the heterogeneous capacity of monocytes to respond to the CNF1 treatment depending on the donors. Here, to determine the importance in natura of AVI the investigators will analyze the blood content of patients presenting E. coli and S. aureus bacteremia. The DNA of monocytes isolated from patients will be extracted and various genes implicated in the activity of various inflammasomes will be sequenced to identify mutations that could explain the susceptibility to bacteremia or a specific clinical presentation, i.e. requirement of a management in ICU because of organ failure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Antibes, France
        • CHG d'Antibes
      • Cannes, France
        • CH Pierre Nouveau
      • Nice, France
        • CHU de Lenval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with S. aureus or E. coli bacteremia defined by at least one positive blood culture

Description

Inclusion Criteria:

  • Patient with S. aureus or E. coli bacteriostatic bacteremia defined by at least one positive blood culture bottle
  • Patient requiring a blood test as part of his bacteremia
  • not subject to a judicial protection measure
  • Signature of the non-opposition of consent (for minor patients signed by one of the parents or the representative of the parental authority)
  • Affiliation to social security

Exclusion Criteria:

  • Immunocompromised patient defined by:

    • current immunosuppressive therapies: corticosteroids, chemotherapy, biotherapy
    • solid organ transplant patient or hematopoietic stem cell transplant
    • chemotherapy-induced neutropenia
    • Congenital immune deficiency
  • bacteremia related to a peripheral or central catheter
  • Urinary obstruction not lifted within the first 24 hours of management
  • Intra-abdominal infection collected undrained in the first 24 hours of management
  • primary infectious focus represented by mechanically ventilated pneumonia
  • Pregnant or lactating woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients presenting E. coli and S. aureus bacteremia
Here, to determine the importance of the mutation we will analyze the blood content of patients presenting E. coli and S. aureus bacteremia
Genetic: Sample analysis
Here, to determine the importance of the mutation we will analyze the blood content of patients presenting E. coli and S. aureus bacteremia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Establish an association between mutations in some inflammasomes and occurrence of E. coli associated with sepsis.
Time Frame: 1 hour
1 hour
Establish an association between mutations in some inflammasomes and occurrence of S. aureus bacteremia associated with sepsis.
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Johan COURJON, MD, Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-AOI-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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