Study and Role of Inflammasome in Platelet Activation During Bacterial And/or Viral Sepsis

NCT06657781 | Recruiting

• 1 other identifier: PAP_RIPH3_2022/03
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bacterial Sepsis

Keywords

Sepsis; platelet; NLRP3; BTK; IL-1β

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Secondary Outcomes (1)

• Confocal Microscopy

  Baseline

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 +.

You may qualify if:

• For groups 1, 2, 3 and 5: Patient with a confirmed sepsis (microbiological confirmation)
• For group 4 : Patient non infected

You may not qualify if:

• Refusal of participation by the patient, his relative or his legal representative (depending on the situation)
• Patients subject to a safeguard measure of justice

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Centre Hospitalier Universitaire de la Guadeloup

Les Abymes, Guadeloupe, 97139, Guadeloupe

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frédéric MARTINO, Doctor

  chu de pointe à pitre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric MARTINO, Doctor

CONTACT

+590 590 89 10 10; frederic.martino@chu-guadeloupe.fr

Study Design

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

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: November 30, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)