protocolSection identificationModule nctId: NCT06381661, orgStudyIdInfo 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-04-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2032-04-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule 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., conditionsModule conditions: Sepsis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo 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, maskingInfo masking: NONE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Tocilizumab, interventions name: Baricitinib, interventions name: Anakinra, interventions name: Hydrocortisone, interventions name: Hydrocortisone and fludrocortisone, interventions name: Heparin, interventions name: Low molecular weight heparin, interventions name: Recombinant humanThrombomodulin( rhTM), interventions name: Sivelestat, interventions name: Fresh frozen plasma, interventions name: Usual care, outcomesModule primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: Number of patients with persistent life-supportive therapies, secondaryOutcomes measure: Composite of the two primary outcomes, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Number of hospital free days, secondaryOutcomes measure: Number of hospital free days, secondaryOutcomes measure: Time to recover walking, secondaryOutcomes measure: Time to resume previous social and professional activities, secondaryOutcomes measure: Quality of life score for adults assessed by SF-36, secondaryOutcomes measure: Quality of life score for adults assessed by EQ-5D-5L, secondaryOutcomes measure: Quality of life score for children assessed by FFS, secondaryOutcomes measure: Quality of life score for adults assessed by SF-36, secondaryOutcomes measure: Quality of life score for adults assessed by EQ-5D-5L, secondaryOutcomes measure: Quality of life score for children assessed by FFS, secondaryOutcomes measure: Quality of life score for adults assessed by SF-36, secondaryOutcomes measure: Quality of life score for adults assessed by EQ-5D-5L, secondaryOutcomes measure: Quality of life score for children assessed by FFS, secondaryOutcomes measure: Number of adverse events, secondaryOutcomes measure: Incidence of new sepsis episodes, secondaryOutcomes measure: Incidence of new sepsis episodes, secondaryOutcomes measure: Incidence of new sepsis episodes, secondaryOutcomes measure: Incidence of new unscheduled hospitalizations, secondaryOutcomes measure: Incidence of new unscheduled hospitalizations, secondaryOutcomes measure: Incidence of new unscheduled hospitalizations, secondaryOutcomes measure: Incidence of sequels in neurocognitive, neuromuscular; cardiovascular, respiratory, renal, metabolic, and immune systems, eligibilityModule sex: ALL, minimumAge: 37 Weeks, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False