nctId: NCT06381661 id: APHP240385 briefTitle: Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial acronym: PALETTE overallStatus: NOT_YET_RECRUITING date: 2026-04-01 date: 2029-05-01 date: 2032-04-01 date: 2024-04-24 date: 2024-04-24 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: 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 pandemic context. conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization will concern 3 specific domains (immunomodulation, coagulation, and corticosteroids); in each domain, patients will be randomly allocated between control (standard of care) and 1-4 experimental treatments using parallell arms primaryPurpose: TREATMENT masking: NONE count: 2000 type: ESTIMATED name: Tocilizumab name: Baricitinib name: Anakinra name: Hydrocortisone name: Hydrocortisone and fludrocortisone name: Heparin name: Low molecular weight heparin name: Recombinant humanThrombomodulin( rhTM) name: Sivelestat name: Fresh frozen plasma name: Usual care measure: All-cause mortality measure: Number of patients with persistent life-supportive therapies measure: Composite of the two primary outcomes measure: Overall Survival measure: Overall Survival measure: Overall Survival measure: Number of hospital free days measure: Number of hospital free days measure: Time to recover walking measure: Time to resume previous social and professional activities measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Number of adverse events measure: Incidence of new sepsis episodes measure: Incidence of new sepsis episodes measure: Incidence of new sepsis episodes measure: Incidence of new unscheduled hospitalizations measure: Incidence of new unscheduled hospitalizations measure: Incidence of new unscheduled hospitalizations measure: Incidence of sequels in neurocognitive, neuromuscular; cardiovascular, respiratory, renal, metabolic, and immune systems sex: ALL minimumAge: 37 Weeks maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False