PALETTE - Trial for personalisation of sepsis treatment in children and adults

2025-521371-31-00 Protocol APHP240923 Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 39 sites · Protocol APHP240923

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 2,000
Countries 1
Sites 39

Sepsis

For each pairwise comparison with the usual care arm, the primary objective is to provide exploratory estimates of the effect of study treatments on all-cause mortality and persistent life-supportive therapies at 28 days after randomization. This will allow to generate hypotheses to be further confirmed thereafter on s…

Key facts

Sponsor
Assistance Publique Hopitaux De Paris
Participant type
Pediatric, Patients
Age range
0-17 years, 18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Virus Diseases [C02]
Decision date (initial)
2025-11-24
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
PHRC 2024 (French Ministry of Health) · IHU-3 SEPSIS · F-CRIN

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

For each pairwise comparison with the usual care arm, the primary objective is to provide exploratory estimates of the effect of study treatments on all-cause mortality and persistent life-supportive therapies at 28 days after randomization. This will allow to generate hypotheses to be further confirmed thereafter on separate confirmatory studies.

Secondary objectives 1

  1. Secondary objectives include exploratory evaluation of the efficacy of treatable-traits guided interventions on sepsis related complications in the short (28 days), mid-term (90 days) and long-term (1 and 3 years), and evaluation of experimental interventions safety profile.

Conditions and MedDRA coding

Sepsis

Regulatory references

Scientific advice from competent authorities
National Agency For The Safety Of Medicine And Health Products
Plan to share IPD
Yes
IPD plan description
All of the individual participant data collected during the trial, subject to compliance to regulations, will be available. Document (Study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code) will be also available. Data will be available immediately following publication ending 2 years after publication, with investigators whose proposed use of the data has been approved by the PI and / or the review commitee if relevant. Proposals should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. All gender patients
  2. Aged >37 weeks corrected gestational age for children
  3. Sepsis as per Sepsis-3 definition for adults (≥18 years), and as per the PHOENIX sepsis for children (age < 18 years). All the following criteria will be required: a. Documented or suspected infection, b. Sequential Organ Failure Assessment (SOFA) score ≥2 for adults, and PHOENIX sepsis score of ≥2 for children.
  4. Health insurance

Exclusion criteria 6

  1. Refused to consent participating in the study
  2. Pregnancy measured by b-HCG blood levels
  3. Breast feeding
  4. Acute coronary disease in the past 3 months
  5. Stroke episode in the past 3 months
  6. Any condition for which patient’s primary physician will consider inappropriate enrolling patient in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Dual primary endpoints will be 1/ 28-day all-cause mortality 2/ Number of days alive without life-supportive therapies (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) at day 28 after randomization

Secondary endpoints 6

  1. Composite and hierarchised of the 2 dual primary outcomes, using a Generalized Pairwise Comparison (GPC) for Prioritized Outcomes,
  2. 90-day, 1-year, and 3-year survival
  3. 1- and 3-years hospital free days
  4. Time to recover walking without aid
  5. Time to resume previous social and professional activities
  6. Quality of life at 90-day, 1-year, and 3-year using, in adults, SF-36, and 5-level EQ-5D version (EQ-5D-5L), and in children the Functional Status Scale (FSS) and the PedsQL.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 11

Dalteparin Sodium

SCP12518807 · ATC

Active substance
Dalteparin Sodium
Route of administration
SUBCUTANEOUS USE
Max daily dose
18000 IU international unit(s)
Max total dose
108000 IU international unit(s)
Max treatment duration
6 Day(s)
Authorisation status
Authorised
ATC code
B01AB04 — DALTEPARIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Anakinra

SCP183367 · ATC

Active substance
Anakinra
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
1000 mg milligram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
L04AC03 — ANAKINRA
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP215120 · ATC

Route of administration
SUBCUTANEOUS
Max daily dose
50 µg/ m2 microgram(s)/ sq. Meter
Max total dose
750 µg/ m2 microgram(s)/ sq. Meter
Max treatment duration
15 Day(s)
Authorisation status
Authorised
ATC code
L03AB03 — INTERFERON GAMMA
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Filgrastim

SCP118777783 · ATC

Active substance
Filgrastim
Substance synonyms
NT100H, FILGRASTIM (GENETICAL RECOMBINATION)
Route of administration
SUBCUTANEOUS
Max daily dose
5 µg/Kg microgram(s)/kilogram
Max total dose
25 µg/Kg microgram(s)/kilogram
Max treatment duration
5 Day(s)
Authorisation status
Authorised
ATC code
L03AA02 — FILGRASTIM
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Heparin

SCP100373670 · ATC

Active substance
Heparin
Substance synonyms
HEPARIINI, HEPARINUM
Route of administration
INTRAVENOUS INFUSION
Max daily dose
0 IU/ml international unit(s)/millilitre
Max total dose
0 IU/ml international unit(s)/millilitre
Max treatment duration
6 Day(s)
Authorisation status
Authorised
ATC code
B01AB01 — HEPARIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Baricitinib

SUB180983 · Substance

Active substance
Baricitinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ENTERAL FEEDING TUBE
Max daily dose
4 mg milligram(s)
Max total dose
28 mg milligram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Baricitinib

SUB180983 · Substance

Active substance
Baricitinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ENTERAL FEEDING TUBE
Max daily dose
2 mg milligram(s)
Max total dose
14 mg milligram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fludrocortisone Acetate

SCP137925 · ATC

Active substance
Fludrocortisone Acetate
Substance synonyms
9ALPHA-FLUOROHYDROCORTISONE 21-ACETATE, FLUOHYDROCORTISONE ACETATE
Route of administration
ORAL, NASOGASTRIC TUBE OR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE USE
Max daily dose
50 µg microgram(s)
Max total dose
350 µg microgram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
H02AA02 — FLUDROCORTISONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tocilizumab

SCP176238 · ATC

Active substance
Tocilizumab
Substance synonyms
RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
Route of administration
SOLUTION FOR INTRAVENOUS INFUSION
Max daily dose
800 mg milligram(s)
Max total dose
800 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L04AC07 — TOCILIZUMAB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Hydrocortisone

SUB08065MIG · Substance

Active substance
Hydrocortisone
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
200 mg milligram(s)
Max total dose
1400 mg milligram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

OCTAPLASLG, solution pour perfusion

PRD3667205 · Product

Active substance
Human Plasma Protein
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
12 millilitre(s)/kilogram
Max total dose
60 millilitre(s)/kilogram
Max treatment duration
5 Day(s)
Authorisation status
Authorised
ATC code
B05AA — BLOOD SUBSTITUTES AND PLASMA PROTEIN FRACTIONS
Marketing authorisation
34009 550 719 7 6
MA holder
OCTAPHARMA FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

251 Total trials 131 Recruiting 54 Ended
Academic / Non-commercial
Sponsor organisation
Assistance Publique Hopitaux De Paris
Address
Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
City
Paris Cedex 10
Postcode
75475
Country
France

Scientific contact point

Organisation
Assistance Publique Hopitaux De Paris
Contact name
Pr Djillali ANNANE

Public contact point

Organisation
Assistance Publique Hopitaux De Paris
Contact name
Pr Djillali ANNANE

Locations

1 EU/EEA country · 39 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 2,000 39
Rest of world — 0 —

Investigational sites

France

39 sites · Authorised, recruitment pending
Assistance Publique Hopitaux De Paris
Intensive care, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Assistance Publique Hopitaux De Paris
Infectiology, 104 Boulevard Raymond Poincare, 92380, Garches
Centre Hospitalier Departemental Vendee
Infectiology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Assistance Publique Hopitaux De Paris
Intensive care, 104 Boulevard Raymond Poincare, 92380, Garches
Centre Hospitalier Universitaire Reims
Infectiology, Rue Du General Koenig, 51092, Reims Cedex
Centre Hospitalier Victor Dupouy
Intensive care, 69 Rue Du Lieutenant Colonel Prudhon, 95107, Argenteuil Cedex
Centre Hospitalier Le Mans
Intensive care, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Sud Essonne-Dourdan-Etampes
Intensive care, 26 Avenue Charles De Gaulle, 91150, Etampes
Centre Hospitalier Universitaire D Orleans
Intensive care, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier Universitaire De Montpellier
Infectiology, 39 Avenue Charles Flahault, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Dijon
Intensive care, 14 Rue Paul Gaffarel, 21000, Dijon
Assistance Publique Hopitaux De Paris
Pediatric intensive care, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Assistance Publique Hopitaux De Paris
Infectiology, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier De Dieppe
Intensive care, 19 Avenue Pasteur, Cs 20219, Dieppe Cedex
Les Hopitaux Universitaires De Strasbourg
Intensive care, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
CHRU De Nancy
Intensive care, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex
Centre Hospitalier Regional Universitaire De Tours
Pediatric intensive care, 49 Boulevard Beranger, 37000, Tours
Hospices Civils De Lyon
Infectiology, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Assistance Publique Hopitaux De Paris
Intensive care, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Assistance Publique Hopitaux De Paris
Pediatric intensive care, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Hospices Civils De Lyon
Pediatric intensive care, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Departemental Vendee
Intensive care, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier De Haguenau
Intensive care, 64 Avenue Du Professeur Rene Leriche, 67500, Haguenau
Les Hopitaux Universitaires De Strasbourg
Pediatric intensive care, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Nantes
Infectiology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Nantes
Intensive care, 30 Boulevard Jean Monnet, 44000, Nantes
Centre Hospitalier Et Universitaire De Limoges
Intensive care, 2 Avenue Martin Luther King, 87000, Limoges
Assistance Publique Hopitaux De Paris
Intensive care, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Assistance Publique Hopitaux De Paris
Infectiology, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Centre Hospitalier Universitaire De Dijon
Infectiology, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Centre Hospitalier Universitaire Reims
Pediatric intensive care, 45 Rue Cognacq Jay, 51100, Reims
Centre Hospitalier Regional Universitaire De Tours
Intensive care, 2 Boulevard Tonnelle, 37000, Tours
Hospices Civils De Lyon
Intensive care, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Assistance Publique Hopitaux De Paris
Intensive care, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Rennes
Intensive care, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier De Tourcoing
Infectiology, 155 Rue Du President Coty, Bp 40619, Tourcoing Cedex
Centre Hospitalier De Bourg-En-Bresse
Intensive care, 900 Route De Paris, 01000, Bourg En Bresse
Centre Hospitalier General De Bastia
Infectiology, P. O. Box 680, 20600, Bastia
Assistance Publique Hopitaux De Paris
Intensive care, 46 Rue Henri Huchard, 75877, Paris Cedex 18

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Appendix-1_Hyperinflammation_trait_2025-521371-31-00_public 2.0
Protocol (for publication) D1_Appendix-2_Hypoinflammation_trait_2025-521371-31-00_public 2.0
Protocol (for publication) D1_Appendix-3_MALS_trait_2025-521371-31-00_public 2.0
Protocol (for publication) D1_Appendix-4_Corticosteroids_trait_2025-521371-31-00_public 2.0
Protocol (for publication) D1_Appendix-5_Hypercoagulation_trait_2025-521371-31-00_public 2.0
Protocol (for publication) D1_Appendix-6_Hypofibrinolysis_trait_2025-521371-31-00_public 2.0
Protocol (for publication) D1_Master_Protocol_2025-521371-31-00_public 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Subject information and informed consent form (for publication) L1_SIS-ICF_autorite-parentale 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_majeur 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_majeur-protege 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_mineur 6-11ans 1.0
Subject information and informed consent form (for publication) L1_SIS-ICF_mineur-12-17ans 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_patient-DCD-utilisation donnees 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_poursuite-majeur 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_poursuite-majeur_protege 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_poursuite-mineur-devenu-majeur 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_poursuite-proche 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_proche 2.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC anakinra 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC baricitinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC dalteparin 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC filgrastim 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC fludrocortisone 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC heparin 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC hydrocortisone_20241202_fr 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC hydrocortisone_20241206_en 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC imukin 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC OCTAPLASLG 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC tocilizumab 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_2025-521371-31-00_public 2.0
Synopsis of the protocol (for publication) D1_Protocol synopsis-layman_2025-521371-31-00 1.0

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-07-29 France Acceptable with conditions
2025-11-17
 2025-11-24
2 SUBSTANTIAL MODIFICATION SM-1 2026-02-12 France Acceptable
2026-05-11
 2026-05-13

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