Escherichia Coli InfectionsNLRP3-BactNCT03869593
Role of the NLRP3 Inflammasome in Escherichia Coli and Staphylococcus Aureus Bacteria
An observational study of Escherichia Coli Infections and Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 75 years
- Conditions the study is for
- Escherichia Coli Infections, Staphylococcus Aureus
- What is being tested?
- Sample analysis
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Jun 2019to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with S. aureus or E. coli bacteremia defined by at least one positive blood culture
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
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.
- Conditions
- Escherichia Coli Infections, Staphylococcus Aureus
- Being tested
- Sample analysis
- Medical subject headings
- Escherichia coli Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample analysisGenetic
Here, to determine the importance of the mutation we will analyze the blood content of patients presenting E. coli and S. aureus bacteremia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Genetic: Sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish an association between mutations in some inflammasomes and occurrence of E. coli associated with sepsis.
Measured: 1 hour
Establish an association between mutations in some inflammasomes and occurrence of S. aureus bacteremia associated with sepsis.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start3 Jun 2019
- Primary completion22 Mar 2022
- Study completion1 Sep 2023
Why it stopped: End of recruitment period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Escherichia Coli InfectionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan COURJON, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869593
- Sponsor's protocol ID
- 18-AOI-08
- Acronym
- NLRP3-Bact
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee CC, Chen SY, Chang IJ, Chen SC, Wu SC. Comparison of clinical manifestations and outcome of community-acquired bloodstream infections among the oldest old, elderly, and adult patients. Medicine (Baltimore). 2007 May;86(3):138-44. doi: 10.1097/SHK.0b013e318067da56.
PubMed 17505253Weinstein MP, Towns ML, Quartey SM, Mirrett S, Reimer LG, Parmigiani G, Reller LB. The clinical significance of positive blood cultures in the 1990s: a prospective comprehensive evaluation of the microbiology, epidemiology, and outcome of bacteremia and fungemia in adults. Clin Infect Dis. 1997 Apr;24(4):584-602. doi: 10.1093/clind/24.4.584.
PubMed 9145732Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis. 2004 Aug 1;39(3):309-17. doi: 10.1086/421946. Epub 2004 Jul 15.
PubMed 15306996Valles J, Palomar M, Alvarez-Lerma F, Rello J, Blanco A, Garnacho-Montero J, Martin-Loeches I; GTEI/SEMICYUC Working Group on Bacteremia. Evolution over a 15-year period of clinical characteristics and outcomes of critically ill patients with community-acquired bacteremia. Crit Care Med. 2013 Jan;41(1):76-83. doi: 10.1097/CCM.0b013e3182676698.
PubMed 23222266Herrmann JB, Muenstermann M, Strobel L, Schubert-Unkmeir A, Woodruff TM, Gray-Owen SD, Klos A, Johswich KO. Complement C5a Receptor 1 Exacerbates the Pathophysiology of N. meningitidis Sepsis and Is a Potential Target for Disease Treatment. mBio. 2018 Jan 23;9(1):e01755-17. doi: 10.1128/mBio.01755-17.
PubMed 29362231Doye A, Chaintreuil P, Lagresle-Peyrou C, Batistic L, Marion V, Munro P, Loubatier C, Chirara R, Sorel N, Bessot B, Bronnec P, Contenti J, Courjon J, Giordanengo V, Jacquel A, Barbry P, Couralet M, Aladjidi N, Fischer A, Cavazzana M, Mallebranche C, Visvikis O, Kracker S, Moshous D, Verhoeyen E, Boyer L. RAC2 gain-of-function variants causing inborn error of immunity drive NLRP3 inflammasome activation. J Exp Med. 2024 Oct 7;221(10):e20231562. doi: 10.1084/jem.20231562. Epub 2024 Aug 30.
PubMed 39212656
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the NLRP3 Inflammasome in Escherichia Coli and Staphylococcus Aureus Bacteria
- ClinicalTrials.gov ID
- NCT03869593
- Acronym / sponsor ID
- NLRP3-Bact / 18-AOI-08
- Conditions
- Escherichia Coli Infections, Staphylococcus Aureus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: End of recruitment period
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting E. coli and S. aureus bacteremia | – | Genetic: Sample analysisHere, to determine the importance of the mutation we will analyze the blood content of patients presenting E. coli and S. aureus bacteremia |
Who may qualify
- Ages
- 8 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with S. aureus or E. coli bacteremia defined by at least one positive blood culture
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Immunocompromised patient defined by:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample analysisHere, to determine the importance of the mutation we will analyze the blood content of patients presenting E. coli and S. aureus bacteremia | Genetic | Patients presenting E. coli and S. aureus bacteremia |
Primary outcome
Establish an association between mutations in some inflammasomes and occurrence of E. coli associated with sepsis.
Time frame: 1 hour
Establish an association between mutations in some inflammasomes and occurrence of S. aureus bacteremia associated with sepsis.
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: End of recruitment period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 17505253Lee CC, Chen SY, Chang IJ, Chen SC, Wu SC. Comparison of clinical manifestations and outcome of community-acquired bloodstream infections among the oldest old, elderly, and adult patients. Medicine (Baltimore). 2007 May;86(3):138-44. doi: 10.1097/SHK.0b013e318067da56.
- Background: PubMed 9145732Weinstein MP, Towns ML, Quartey SM, Mirrett S, Reimer LG, Parmigiani G, Reller LB. The clinical significance of positive blood cultures in the 1990s: a prospective comprehensive evaluation of the microbiology, epidemiology, and outcome of bacteremia and fungemia in adults. Clin Infect Dis. 1997 Apr;24(4):584-602. doi: 10.1093/clind/24.4.584.
- Background: PubMed 15306996Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis. 2004 Aug 1;39(3):309-17. doi: 10.1086/421946. Epub 2004 Jul 15.
- Background: PubMed 23222266Valles J, Palomar M, Alvarez-Lerma F, Rello J, Blanco A, Garnacho-Montero J, Martin-Loeches I; GTEI/SEMICYUC Working Group on Bacteremia. Evolution over a 15-year period of clinical characteristics and outcomes of critically ill patients with community-acquired bacteremia. Crit Care Med. 2013 Jan;41(1):76-83. doi: 10.1097/CCM.0b013e3182676698.
- Background: PubMed 29362231Herrmann JB, Muenstermann M, Strobel L, Schubert-Unkmeir A, Woodruff TM, Gray-Owen SD, Klos A, Johswich KO. Complement C5a Receptor 1 Exacerbates the Pathophysiology of N. meningitidis Sepsis and Is a Potential Target for Disease Treatment. mBio. 2018 Jan 23;9(1):e01755-17. doi: 10.1128/mBio.01755-17.
- Results publication: PubMed 39212656Doye A, Chaintreuil P, Lagresle-Peyrou C, Batistic L, Marion V, Munro P, Loubatier C, Chirara R, Sorel N, Bessot B, Bronnec P, Contenti J, Courjon J, Giordanengo V, Jacquel A, Barbry P, Couralet M, Aladjidi N, Fischer A, Cavazzana M, Mallebranche C, Visvikis O, Kracker S, Moshous D, Verhoeyen E, Boyer L. RAC2 gain-of-function variants causing inborn error of immunity drive NLRP3 inflammasome activation. J Exp Med. 2024 Oct 7;221(10):e20231562. doi: 10.1084/jem.20231562. Epub 2024 Aug 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan COURJON, MD principal investigator
Centre Hospitalier Universitaire de Nice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Escherichia Coli Infections and Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of recruitment period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish an association between mutations in some inflammasomes and occurrence of E. coli associated with sepsis. (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869593, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.