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

• Status: NOT_YET_RECRUITING
• Trial end date: 2032-04-01

Summary

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.

• Phase: PHASE3

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: baricitinib; Fludrocortisone; Heparin; Heparin, Low-Molecular-Weight; Hydrocortisone; Interleukin 1 Receptor Antagonist Protein; sivelestat; tocilizumab