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

Study acronym: PALETTE
StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Jun 1, 2028 → Aug 9, 2028
See other at-risk trials from Assistance Publique - Hôpitaux de Paris

Record History

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  1. Trial sites expanded: 8 → 19 locations
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 13 of 29 entries
  2. Recruitment openedv3 Show 4 more changesShow less
    • Primary completion pushed from Jun 1, 2028 to Aug 9, 2028
    • Trial sites expanded: 0 → 8 locations
    • Study completion pushed from May 1, 2031 to Jul 9, 2031
    • Start date changed from estimate of May 1, 2026 to Jul 9, 2026
  3. Phase: Phase 3 to Phase 2v2 Show 9 more changesShow less
    • Start date: Apr 1, 2026 to May 1, 2026
    • Primary endpoints revised (2)
    • Primary completion date: May 1, 2029 to Jun 1, 2028
    • Study completion date: Apr 1, 2032 to May 1, 2031
    • Interventions: Anakinra (Drug), Baricitinib (Drug), Fresh frozen plasma (Biological), Heparin (Drug), Hydrocortisone (Drug), Hydrocortisone and… to Anakinra (Drug), Baricitinib (Drug), Fludrocortisone (Drug), G-CSF filgrastim (Drug), Heparin (Drug), Hydrocortisone (Drug), Hydrocortisone…
    • Eligibility criteria shortened, about 29 words
    • Secondary endpoints: 25 to 29
    • Study arms: 11 to 24
    • Study title expanded, about 1 word
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06381661
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)		 Sepsis
Related terms Sepsis
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov