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Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial

RecruitingPhase 2Ages 37 Weeks - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pand

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Platform inclusion criteria will be: * All genders patients * Aged \>37 weeks corrected gestational age * Sepsis as per Sepsis-3 definition for adults, and as per the PHOENIX sepsis for children Briefly, all following criteria will be required: 1. Documented or suspected infection, 2. Sequential Organ Failure Assessment (SOFA) score ≥2 for adults, and PHOENIX sepsis score of ≥2 for children. * Health insurance Platform exclusion criteria: Any of the following: * Refusal to consent for participating in the study, * Pregnancy measured by beta-HCG blood levels * Breast feeding * Acute coronary disease in the past 3 months * Stroke episode in the past 3 months * Any condition for which patient's primary physician will consider inappropriate enrolling patient in the study Treatable trait inclusion criteria : * Hyperinflammation : Subphenotypes Beta, Delta, Gamma for adults; Subphenotypes PedSep-B, C, D for children * Hypoinflammation : lymphocytes count \< 1.0 × 10\^9/L * Macrophage Activation Like Syndrome : Ferritin \>4,420 ng/mL for adults, Ferritin \>500 ng/mL for children * Corticosteroids: Positive for i-RECORDS algorithm signature * Hypercoagulation (adults) : Prothrombin time (PT)/INR ≥ 1.40 AND Platelet count \< 150 000/mm3 or greater than 30% decrease in platelets in 24 hours * Hypofibrinolysis (adults): Plasminogen deficit \< 0.5 µmol/L There are also inclusion and exclusion criteria related to treatable traits and interventions.
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What it tests

  • Tocilizumab
  • Baricitinib
  • Anakinra
  • Hydrocortisone
  • Hydrocortisone and fludrocortisone
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Where

19 sites
CHU Dijon - infectiologie
Dijon, France
CHU Dijon - réanimation adulte
Dijon, France
CH Sud Essonne - site d'Etampes - Réanimation adulte
Étampes, France
Hôpital Raymond Poincaré - infectiologie
Garches, France
Hôpital Raymond Poincaré
Garches, France
CH de Haguenau
Haguenau, France
CHD Vendée - infectiologie
La Roche-sur-Yon, France
CHD Vendée - réanimation adulte
La Roche-sur-Yon, France

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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