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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06381661
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
37 Weeks - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    8 mg per kilogram of body weight enterally (oral or via a gastric tube) once daily for 14 days (or hospital discharge pending which will occur first) (same for adults and children)
  • Baricitinib — DRUG
    4mg, enterally (oral or via a gastric tube) once daily for 14 days (or hospital discharge pending which will occur first) (same for adults and children)
  • Anakinra — DRUG
    100 mg subcutaneously once daily for 10 days (or hospital discharge pending which will occur first) (same for adults and children)
  • Hydrocortisone — DRUG
    50mg (in children: 1-2 mg/kg) IV Q6 for 7 days
  • Hydrocortisone and fludrocortisone — DRUG
    Hydrocortisone 50mg IV Q6 for 7 days + Fludrocortisone 50mg orally or via gastric tube once a day for 7 days.
  • Heparin — DRUG
    Therapeutic unfractionated heparin (UFH) starting at 400 (in children: 20 IU/kg/h) IU/kg/24h (target between 0.3 and 0.5 IU/ml), adapted to the therapeutic Partial Thromboplastin Time targeting values in the range of 60 to 100 seconds, with lower intensity dosing in the range of 60 to 80 seconds, for 7 days (or ICU discharge, pending which will occur first).
  • Low molecular weight heparin — DRUG
    Therapeutic low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: 175 (in children 100 U/kg) IU/kg/24h, for 7 days (or hospital discharge pending which will occur first).
  • Recombinant humanThrombomodulin( rhTM) — DRUG
    Recombinant human thrombomodulin (rhTM) 0.06 mg/kg/j IV, for 7 days (or ICU discharge, pending which will occur first).
  • Sivelestat — DRUG
    0.2 mg/kg/h for 7 days (or ICU discharge, pending which will occur first)
  • Usual care — OTHER
    Usual care
  • blood purification with MTx.100 Plasma Adsorption Column — OTHER
    up to 4 hours a day, up to four days in a row
  • G-CSF filgrastim — DRUG
    0.5 MIU (5μg)/kg/day subcutaneously for 5 consecutive days (or up to ICU discharge pending which occurs first) - same for adults and children .
  • Interferon gamma-1b — DRUG
    rhIFNg subcutaneously at 50 µg/m2 if body surface \>0,5 m2, or 1.5µg/kg if body surface of 0,5 m2or less, every other day for 15 days (or up to ICU discharge pending which occurs first)
  • Fludrocortisone — DRUG
    50µg orally (or via the gastric tube) once a day for 7 days (or ICU discharge pending which will occur first) (same for adults and children)
  • Prophylactic unfractionated heparin (UFH) — DRUG
    100 IU/kg/24h for 6 days
  • Octaplas LG — DRUG
    12 mL/kg on day 1; repeated daily from day 2 to day 5, provided that PT/INR remains ≥ 1.40 (This intervention will be opened for randomisation once a supply circuit is in place)
  • Plasminogen — DRUG
    2,2 mg/kg/day (intravenous infusion) during 3 days.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Jan 2026
Primary completion
Jun 1, 2028
Completion
May 1, 2031

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hyperinflammation : Tocilizumab
  • Experimental: Hyperinflammation: Baricitinib
  • Experimental: Hyperinflammation: Anakinra
  • Experimental: Hyperinflammation : blood purification with MTx.100 Plasma Adsorption Column
  • Active Comparator: Hyperinflammation : usual care
  • Experimental: Hypoinflammation : G CSF filgrastim
  • Experimental: Hypoinflammation : Interferon gamma-1b
  • Active Comparator: Hypoinflammation : usual care
  • Experimental: MALS : Anakinra
  • Experimental: MALS : blood purification with MTx.100 Plasma Adsorption Column
  • Active Comparator: MALS : usual care
  • Experimental: Corticoids response : Hydrocortisone
  • Experimental: Corticoids response : Fludrocortisone
  • Experimental: Corticoids response : Hydrocortisone + Fludrocortisone
  • Active Comparator: Corticoids response : usual care
  • Experimental: Hypercoagulation : Prophylactic unfractionated heparin (UFH)
  • Experimental: Hypercoagulation : Therapeutic UFH
  • Experimental: Hypercoagulation : Therapeutic low molecular weight heparin (LMWH)
  • Experimental: Hypercoagulation : Thrombomodulin
  • Active Comparator: Hypercoagulation : usual care
  • Experimental: Hypofrinolysis : Sivelestat
  • Experimental: Hypofrinolysis : OctaplasLG
  • Experimental: Hypofrinolysis : Plasminogen
  • Active Comparator: Hypofrinolysis : Usual care

Primary Outcome Measure

All-cause mortality [ Time Frame: At day 28 ]

Central Contacts

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