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NCT Number: NCT06381661

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

37 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Documented or suspected infection,
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. All-cause mortality

    Time frame: At day 28

    Dual primary endpoint

  2. Number of days alive without persistent life-supportive therapies

    Time frame: At day 28

    Dual primary endpoint Respiratory support: high flow oxygen, non-invasive or invasive mechanical ventilation, extracorporeal membrane oxygenation or CO2 removal; cardiovascular support: continuous infusion of any dose of vasopressor or inotrope, or mechanical circulatory assistance; renal support: intermittent or continuous renal replacement therapy

Secondary outcomes

  1. Net benefit probability of intervention vs. control, assessed with a Generalized Pairwise Comparison (mortality prioritized over life-support-free days)

    Time frame: At day 28

    The Generalized Pairwise Comparison (GPC) method will be used to derive a single composite outcome. Each patient in the intervention group will be compared to each patient in the control group. For each pair, a score of +1, -1, or 0 will be assigned according to prioritized outcomes: (1) all-cause mortality at day 28, and (2) number of days alive without life-supportive therapies at day 28 if both patients have the same mortality status. The net benefit will be calculated as the sum of all pairwise scores divided by the total number of pairs, corresponding to the probability that a randomly chosen patient has a better outcome in one group than in the other.

  2. Overall Survival

    Time frame: At day 90

  3. Overall Survival

    Time frame: At 1 year

  4. Overall Survival

    Time frame: At 3 years

  5. Number of hospital free days

    Time frame: At 1 year

  6. Number of hospital free days

    Time frame: At 3 years

  7. Time to recover walking

    Time frame: At day 90

  8. Time to resume previous social and professional activities

    Time frame: At 1 year

  9. Quality of life score for adults assessed by SF-36

    Time frame: At day 90

    The Short Form (36) (SF-36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.

    Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.

  10. Quality of life score for adults assessed by EQ-5D-5L

    Time frame: At day 90

    EQ-5D-5L : It evaluates five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. Answers are given on a 5-point scale by domain, the higher the score, the poorer the quality of life.

  11. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: At day 90

    Standardized tool used to measure health-related quality of life (HRQoL) in children and adolescents (ages 2-18) It is a 23-item score divided in four domains : Phtsical functioning, Emotional functioning, Social functioning, School functioning The total score vary from 0 to 100. The higher the score the hiher the quality of life.

  12. Quality of life score for children assessed by FSS

    Time frame: At day 90

    Functional Status Scale (FFS) : It examines 6 domains of functioning, and each domain receives a score of 1 (normal), 2 (mild dysfunction), 3 (moderate dysfunction), 4 (severe dysfunction), or 5 (very severe dysfunction). Final scores range from 6 to 30.

  13. Quality of life score for adults assessed by SF-36

    Time frame: At 1 year

    The Short Form (36) (SF-36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.

    Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.

  14. Quality of life score for adults assessed by EQ-5D-5L

    Time frame: At 1 year

    EQ-5D-5L : It evaluates five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. Answers are given on a 5-point scale by domain, the higher the score, the poorer the quality of life.

  15. Quality of life score for children assessed by FSS

    Time frame: At 1 year

    Functional Status Scale (FFS) : It examines 6 domains of functioning, and each domain receives a score of 1 (normal), 2 (mild dysfunction), 3 (moderate dysfunction), 4 (severe dysfunction), or 5 (very severe dysfunction). Final scores range from 6 to 30.

  16. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: At 1 year

    Standardized tool used to measure health-related quality of life (HRQoL) in children and adolescents (ages 2-18) It is a 23-item score divided in four domains : Phtsical functioning, Emotional functioning, Social functioning, School functioning The total score vary from 0 to 100. The higher the score the hiher the quality of life.

  17. Quality of life score for adults assessed by SF-36

    Time frame: At 3 years

    The Short Form (36) (SF-36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.

    Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.

  18. Quality of life score for adults assessed by EQ-5D-5L

    Time frame: At 3 years

    EQ-5D-5L : It evaluates five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. Answers are given on a 5-point scale by domain, the higher the score, the poorer the quality of life.

  19. Quality of life score for children assessed by FSS

    Time frame: At 3 years

    Functional Status Scale (FFS) : It examines 6 domains of functioning, and each domain receives a score of 1 (normal), 2 (mild dysfunction), 3 (moderate dysfunction), 4 (severe dysfunction), or 5 (very severe dysfunction). Final scores range from 6 to 30.

  20. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: At 3 years

    Standardized tool used to measure health-related quality of life (HRQoL) in children and adolescents (ages 2-18) It is a 23-item score divided in four domains : Phtsical functioning, Emotional functioning, Social functioning, School functioning The total score vary from 0 to 100. The higher the score the hiher the quality of life.

  21. Number of adverse events

    Time frame: Up to 3 years

    Tolerance of interventions considering any grade of 3 serious adverse events.

  22. Incidence of new sepsis episodes

    Time frame: At day 90

  23. Incidence of new sepsis episodes

    Time frame: At 1 year

  24. Incidence of new sepsis episodes

    Time frame: At 3 years

  25. Incidence of new unscheduled hospitalizations

    Time frame: At day 90

  26. Incidence of new unscheduled hospitalizations

    Time frame: At 1 year

  27. Incidence of new unscheduled hospitalizations

    Time frame: At 3 years

  28. Incidence of sequels in neurocognitive, neuromuscular; cardiovascular, respiratory, renal, metabolic, and immune systems

    Time frame: At 3 years

  29. Number of grade 3 serious adverse events

    Time frame: At day 28

Other outcomes

  1. Circulating levels of cytokines

    Time frame: At inclusion

  2. Circulating levels of chemokines

    Time frame: At inclusion

  3. Circulating levels of cytokines

    Time frame: At day 1

  4. Circulating levels of chemokines

    Time frame: At day 1

  5. Circulating levels of cytokines

    Time frame: At day 7

  6. Circulating levels of chemokines

    Time frame: At day 7

  7. Circulating levels of cytokines

    Time frame: At 1 year

  8. Circulating levels of chemokines

    Time frame: At 1 year

  9. Circulating levels of cytokines

    Time frame: At 3 years

  10. Circulating levels of chemokines

    Time frame: At 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Djillali Annane, Pr

CONTACT

[email protected]

+33147107787

Jérôme Lambert

CONTACT

[email protected]

+33142499742

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PALETTE

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Apr 24, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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