Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial
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.
Timeline
- Start
- 2026-05-01
- Primary completion
- 2028-06-01
- Completion
- 2031-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |
| Subject | Baricitinib | Small molecule | 4 mg | Oral |
| Subject | Fludrocortisone | Other / unclassified | 50 ug | Oral |
| Subject | Fludrocortisone | Other / unclassified | 50 mg | Oral |
| Subject | Heparin | Other / unclassified | 20 iu/kg | — |
| Subject | Heparin | Other / unclassified | 100 iu/kg | — |
| Subject | Heparin | Other / unclassified | 400 iu/kg | — |
| Subject | Hydrocortisone | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | Hydrocortisone | Other / unclassified | 2 mg/kg | Intravenous |
| Subject | Hydrocortisone | Other / unclassified | 50 mg | Intravenous |
| Subject | Interferon gamma-1b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Subject | Interferon gamma-1b | Protein / enzyme biologic | 50 ug/m2 | Subcutaneous |
| Subject | Octaplas LG | Other / unclassified | 12 ml | — |
| Subject | Plasminogen | Unknown | 2.2 mg/kg | Intravenous |
| Subject | Sivelestat | Small molecule | 0.2 mg/kg | — |
| Subject | Thrombomodulin | Unknown | 0.06 mg/kg | Intravenous |
| Subject | Tinzaparin | Other / unclassified | 100 iu/kg | — |
| Subject | Tinzaparin | Other / unclassified | 175 iu/kg | — |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Oral |
| Subject | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |