Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT06381661
Eligibility Criteria:
Inclusion Criteria:
* All genders patients aged \>37 weeks corrected gestational age with sepsis as per Sepsis-3 definition for adults, and as per the PHOENIX sepsis for children
* documented or suspected infection
* a Sequential Organ Failure Assessment (SOFA) score ≥2 for adults, and PHOENIX sepsis score of ≥2 for children.
Domain specific additional inclusion criteria :
1. Hyper or hypo inflammation based
* For adults on, respectively: beta, delta and gamma sub-phenotypes, and/or circulating levels of IL-6 \> 100pg/mL, and lymphocytes counts \< 1.0 × 109/L and/or HLA-DR \<5,000 HLA-DR receptors/monocytes
* For children on: the PODIUM (+specific criteria for children)
2. Corticosteroids domain Corticosteroids responses based on the combination of Glucocorticoid-induced 1 GLCCI1) AA and nuclear factor (NF)-KB1 DI genotypes.
3. Coagulation domain
* Hypercoagulation state defined as a SIC score ≥4 points and neutrophils side fluorescence light (NEUT-SFL) \>66 Arbitrary Units (patients with disseminated intravascular coagulopathy, DIC) or NEUT-SFL ≤66 AU (septic coagulopathy)
* Hypofibrinolytic state defined as SIC score ≥4 points and decreased plasminogen level \<1.2 nM.
Exclusion Criteria:
* refused to consent participating in the study
* pregnancy
* any condition for which patient's primary physician will consider inappropriate enrolling patient in the study
* previous enrollment in the study.
* additional domain specific exclusion criteria relevant to specific interventions, i.e. tocilizumab, baricitinib, anakinra, hydrocortisone, fludrocortisone, unfractioned heparin, tinzaparin, human recombinant thrombomodulin, sivelestat, fresh frozen plasma, according to the "base de données publiques des medicaments"
Patients can be included in multiple domains.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
37 Weeks
Maximum Age:
100 Years
Study:
NCT06381661
Study Brief:
Protocol Section:
NCT06381661