Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-09
Brief Title:
Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults a Multi-national Treatable Traits-guided Adaptive Bayesian Basket Trial
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
PALETTE- 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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALETTE
Brief 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 PALETTEs new conceptual model will respond to the challenges of standard approaches ie series of sepsis trials each investigating one or two interventions expensive time consuming and inappropriate in pandemic context
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None