Role of the NLRP3 Inflammasome in Escherichia Coli and Staphylococcus Aureus Bacteria (NCT03869593) | Clinical Trial Compass
TerminatedNot Applicable
Role of the NLRP3 Inflammasome in Escherichia Coli and Staphylococcus Aureus Bacteria
Stopped: End of recruitment period
France60 participantsStarted 2019-06-03
Plain-language summary
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.
Who can participate
Age range
8 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Establish an association between mutations in some inflammasomes and occurrence of E. coli associated with sepsis.
Timeframe: 1 hour
2
Establish an association between mutations in some inflammasomes and occurrence of S. aureus bacteremia associated with sepsis.