Bacterial SepsisPLAQSEPSISNCT06657781
Study and Role of Inflammasome in Platelet Activation During Bacterial And/or Viral Sepsis
An observational study of Bacterial Sepsis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
: Sepsis, now defined as life-threatening organ dysfunction due to a dysregulated host response to infection, is an important global health problem representing about a fifth of all global deaths. It can be associated, in some cases, with multiple organ failure and cytokine storm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Sepsis
- How many people
- 171 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 30 Nov 2022to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thirty patients will be included in each group: patients with leptospirosis, patients with bacterial infections including in-hospital-acquired-infections, patients with viral infection, patients non infected (control group). Fifty-one patients will be included in group of patients with viral infection SARS-COv2 +.
Who may be able to join
- For all groups: patients older than 18 years at inclusion and acceptation of participation by the patient, his relative or his legal representative (depending on the situation)
- For groups 1, 2, 3 and 5: Patient with a confirmed sepsis (microbiological confirmation)
- For group 4 : Patient non infected
Who cannot join
- Refusal of participation by the patient, his relative or his legal representative (depending on the situation)
- Patients subject to a safeguard measure of justice
- Patients younger than 18 years at inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de la Guadeloup
Les Abymes, Guadeloupe, 97139
Valérie SOTER, +590 590 934677, valerie.soter@chu-guadeloupe.fr
Eunice NUBRET, +590 590 934686, eunice.nubret@chu-guadeloupe.fr
About this study
: Sepsis, now defined as life-threatening organ dysfunction due to a dysregulated host response to infection, is an important global health problem representing about a fifth of all global deaths. It can be associated, in some cases, with multiple organ failure and cytokine storm. The main objective of this study is to estimate and to compare the activation rate of the Nucleotide-binding domain Leucine Rich repeat containing Protein 3 (NLRP3) inflammasome in platelets between five groups of patients suffering from bacterial and/or viral sepsis, with different severity levels according to Sequential Organ Failure Assessment (SOFA) score to precise the platelets' implication in this cytokine storm.
Read the detailed description
Patients with bacterial or vial sepsis have been shown to exhibit very high levels of pro-inflammatory cytokines (IL1, IL6, IFN, IP10 and MCP1) that may activate the T-helper-1 lymphocytic response (Th1). These cytokines can be produced by several cell types, including blood platelets. IL1 is an important pro-inflammatory cytokine whose expression is increased in various pro-inflammatory contexts, including dengue infection. It induces an increase in endothelial permeability and a pro-thrombotic state, as described in patients infected with COVID-19. It is synthesized as a protein precursor that is cleaved by the NLRP3 (Nucleotide-binding domain Leucine repeat Rich containing Protein 3). Close associations between the deregulation of inflammasome activity and hereditary or acquired diseases suggest an important role of NLRP3 inflammasome in regulating immune responses. The activation of the NLRP3 inflammasome increases caspase 1 activity and induces the production of bioactive IL1 as well as other pro-inflammatory cytokines such as IL18. The major role of NLRP3 platelet inflammasome in the "cytokine storm" has been highlighted in the case of Dengue virus infection. We hypothesize that blood platelets may play an important role in the inflammatory response observed during sepsis through the activation of NLRP3 inflammasome, particularly during its exacerbation.
- Five groups of patients will be constituted: patients with leptospirosis, patients with bacterial infections including in-hospital-acquired-infections, patients with viral infection, patients non infected (control group), patients with viral infection SARS-COv2 +.
- Only one blood collection will be realized
- Conditions
- Bacterial Sepsis
- Keywords
- Sepsis, platelet, NLRP3, BTK, IL-1β
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| leptospirosis | patient suffering from leptospirosis | |
| bacterial | patient suffering from bacterial infections including in-hospital-acquired-infections | |
| viral | patient suffering from viral infection except COVID-19 | |
| Control | patients non infected | |
| viral infection SARS-COv2 + | patient suffering from COVID-19 previously enrolled in PLAQCOVID trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nucleotide-binding domain Leucine Rich repeat containing Protein 3 activation
The primary outcome will be the evaluation of platelets' NLRP3 activation in septic patients according to the severity of the disease
Measured: Baseline
Secondary outcomes (1)
Confocal Microscopy
We aim to confirm the colocalization of NRLP3/ASC in inflammasome activation by confocal microscopy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start30 Nov 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial SepsisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric MARTINO, Doctor, Principal investigator, chu de pointe à pitre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657781
- Sponsor's protocol ID
- PAP_RIPH3_2022/03
- Acronym
- PLAQSEPSIS
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study and Role of Inflammasome in Platelet Activation During Bacterial And/or Viral Sepsis
- ClinicalTrials.gov ID
- NCT06657781
- Acronym / sponsor ID
- PLAQSEPSIS / PAP_RIPH3_2022/03
- Conditions
- Bacterial Sepsis
- Keywords
- Sepsis, platelet, NLRP3, BTK, IL-1β
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Oct 2024 (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.
: Sepsis, now defined as life-threatening organ dysfunction due to a dysregulated host response to infection, is an important global health problem representing about a fifth of all global deaths. It can be associated, in some cases, with multiple organ failure and cytokine storm. The main objective of this study is to estimate and to compare the activation rate of the Nucleotide-binding domain Leucine Rich repeat containing Protein 3 (NLRP3) inflammasome in platelets between five groups of patients suffering from bacterial and/or viral sepsis, with different severity levels according to Sequential Organ Failure Assessment (SOFA) score to precise the platelets' implication in this cytokine storm.
Detailed description
Patients with bacterial or vial sepsis have been shown to exhibit very high levels of pro-inflammatory cytokines (IL1, IL6, IFN, IP10 and MCP1) that may activate the T-helper-1 lymphocytic response (Th1). These cytokines can be produced by several cell types, including blood platelets. IL1 is an important pro-inflammatory cytokine whose expression is increased in various pro-inflammatory contexts, including dengue infection. It induces an increase in endothelial permeability and a pro-thrombotic state, as described in patients infected with COVID-19. It is synthesized as a protein precursor that is cleaved by the NLRP3 (Nucleotide-binding domain Leucine repeat Rich containing Protein 3). Close associations between the deregulation of inflammasome activity and hereditary or acquired diseases suggest an important role of NLRP3 inflammasome in regulating immune responses. The activation of the NLRP3 inflammasome increases caspase 1 activity and induces the production of bioactive IL1 as well as other pro-inflammatory cytokines such as IL18. The major role of NLRP3 platelet inflammasome in the "cytokine storm" has been highlighted in the case of Dengue virus infection. We hypothesize that blood platelets may play an important role in the inflammatory response observed during sepsis through the activation of NLRP3 inflammasome, particularly during its exacerbation.
- Five groups of patients will be constituted: patients with leptospirosis, patients with bacterial infections including in-hospital-acquired-infections, patients with viral infection, patients non infected (control group), patients with viral infection SARS-COv2 +.
- Only one blood collection will be realized
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| leptospirosis | – | –patient suffering from leptospirosis |
| bacterial | – | –patient suffering from bacterial infections including in-hospital-acquired-infections |
| viral | – | –patient suffering from viral infection except COVID-19 |
| Control | – | –patients non infected |
| viral infection SARS-COv2 + | – | –patient suffering from COVID-19 previously enrolled in PLAQCOVID trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients will be included in each group: patients with leptospirosis, patients with bacterial infections including in-hospital-acquired-infections, patients with viral infection, patients non infected (control group). Fifty-one patients will be included in group of patients with viral infection SARS-COv2 +.
Key inclusion criteria (3 listed)
- For all groups: patients older than 18 years at inclusion and acceptation of participation by the patient, his relative or his legal representative (depending on the situation)
- For groups 1, 2, 3 and 5: Patient with a confirmed sepsis (microbiological confirmation)
- For group 4 : Patient non infected
Key exclusion criteria (3 listed)
- Refusal of participation by the patient, his relative or his legal representative (depending on the situation)
- Patients subject to a safeguard measure of justice
- Patients younger than 18 years at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nucleotide-binding domain Leucine Rich repeat containing Protein 3 activation
Time frame: Baseline
The primary outcome will be the evaluation of platelets' NLRP3 activation in septic patients according to the severity of the disease
1 secondary outcome
Confocal Microscopy
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- 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.
Frédéric MARTINO, Doctor principal investigator
chu de pointe à pitre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Sepsis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric MARTINO, Doctor (+590 590 89 10 10, frederic.martino@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nucleotide-binding domain Leucine Rich repeat containing Protein 3 activation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2024.