NCT06381661 Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial
| NCT ID | NCT06381661 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2026-07-09 |
| Primary Completion | 2028-08-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 2,000 participants in total. It began in 2026-07-09 with a primary completion date of 2028-08-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
Platform inclusion criteria will be: * All genders patients * Aged \>37 weeks corrected gestational age * Sepsis as per Sepsis-3 definition for adults, and as per the PHOENIX sepsis for children Briefly, all following criteria will be required: 1. Documented or suspected infection, 2. Sequential Organ Failure Assessment (SOFA) score ≥2 for adults, and PHOENIX sepsis score of ≥2 for children. * Health insurance Platform exclusion criteria: Any of the following: * Refusal to consent for participating in the study, * Pregnancy measured by beta-HCG blood levels * Breast feeding * Acute coronary disease in the past 3 months * Stroke episode in the past 3 months * Any condition for which patient's primary physician will consider inappropriate enrolling patient in the study Treatable trait inclusion criteria : * Hyperinflammation : Subphenotypes Beta, Delta, Gamma for adults; Subphenotypes PedSep-B, C, D for children * Hypoinflammation : lymphocytes count \< 1.0 × 10\^9/L * Macrophage Activation Like Syndrome : Ferritin \>4,420 ng/mL for adults, Ferritin \>500 ng/mL for children * Corticosteroids: Positive for i-RECORDS algorithm signature * Hypercoagulation (adults) : Prothrombin time (PT)/INR ≥ 1.40 AND Platelet count \< 150 000/mm3 or greater than 30% decrease in platelets in 24 hours * Hypofibrinolysis (adults): Plasminogen deficit \< 0.5 µmol/L There are also inclusion and exclusion criteria related to treatable traits and interventions.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06381661 clinical trial?
This trial is open to participants of all sexes, aged 37 Weeks or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06381661 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06381661 currently recruiting?
Yes, NCT06381661 is actively recruiting participants. Contact the research team at djillali.annane@aphp.fr for enrollment information.
Where is the NCT06381661 trial being conducted?
This trial is being conducted at Dijon, France, Dijon, France, Garches, France, Garches, France and 4 additional locations.
Who is sponsoring the NCT06381661 clinical trial?
NCT06381661 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 2,000 participants.