Clinical trial • Phase II/III • Infectious Disease

ANAKINRA for Sepsis

Phase II/III trial of ANAKINRA for Sepsis. Randomised, usual care arm (usual care); not further specified in provided documents-controlled, adaptive.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Sepsis
Trial Stage
Phase II/III
Drug Modality
Peptide/protein/enzyme|Monoclonal antibody|Small molecule|Other
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
29-07-2025
First CTIS Authorization Date
24-11-2025

Trial design

Randomised, usual care arm (usual care); not further specified in provided documents-controlled, adaptive Phase II/III trial in France.

Randomised
Yes
Comparator
Usual care arm (usual care); not further specified in provided documents
Adaptive
True, adaptive platform design: treatable-traits-guided, exploratory Bayesian basket trial with pairwise comparisons versus a usual care arm and platform features to evaluate multiple experimental interventions across traits.
Target Sample Size
2000
Trial Duration For Participant
1095

Eligibility

Recruits 2000 paediatric patients.

Pregnancy Exclusion
Pregnancy measured by b-HCG blood levels
Vulnerable Population
isVulnerablePopulationSelected is true. The trial includes children (<18 years). Age-specific information and consent documents are provided (e.g. L1_SIS-ICF_mineur 6-11ans, L1_SIS-ICF_mineur-12-17ans) as well as parental authorization form (L1_SIS-ICF_autorite-parentale) and continuation/assent forms (e.g. L1_SIS-ICF_poursuite-mineur-devenu-majeur). Consent/assent and guardian/parental authorization processes are specified via these documents.

Inclusion criteria

  • {"criterion_text":"- All gender patients\n- Aged >37 weeks corrected gestational age for children\n- 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.\n- Health insurance"}

Exclusion criteria

  • {"criterion_text":"- Refused to consent participating in the study\n- Pregnancy measured by b-HCG blood levels\n- Breast feeding\n- Acute coronary disease in the past 3 months\n- Stroke episode in the past 3 months\n- Any condition for which patient’s primary physician will consider inappropriate enrolling patient in the study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Primary endpoints measured at day 28 after randomization: 1) all-cause mortality at 28 days; 2) number of days alive without life-supportive therapies up to day 28. Life-supportive therapies are defined in the endpoint text and include specified respiratory, cardiovascular and renal supports."}

Secondary endpoints

  • {"endpoint_text":"- Composite and hierarchised of the 2 dual primary outcomes, using a Generalized Pairwise Comparison (GPC) for Prioritized Outcomes,","definition_or_measurement_approach":"Composite and hierarchical analysis of the two primary outcomes using Generalized Pairwise Comparison (GPC) for prioritized outcomes."}
  • {"endpoint_text":"- 90-day, 1-year, and 3-year survival","definition_or_measurement_approach":"Survival status assessed at 90 days, 1 year and 3 years."}
  • {"endpoint_text":"- 1- and 3-years hospital free days","definition_or_measurement_approach":"Number of hospital-free days assessed at 1 and 3 years."}
  • {"endpoint_text":"- Time to recover walking without aid","definition_or_measurement_approach":"Time (days) to recovery of independent walking."}
  • {"endpoint_text":"- Time to resume previous social and professional activities","definition_or_measurement_approach":"Time to resume pre-sepsis social and professional activities."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Quality of life assessed using SF-36 and EQ-5D-5L in adults, and FSS and PedsQL in children at 90 days, 1 year and 3 years."}

Recruitment

Planned Sample Size
2000
Recruitment Window Months
60
Consent Approach
Informed consent is documented with multiple subject information and informed consent forms: adult forms (L1_SIS-ICF_majeur), protected adult forms (L1_SIS-ICF_majeur-protege), continuation forms, parental authorization (L1_SIS-ICF_autorite-parentale), and age-specific minor forms (L1_SIS-ICF_mineur 6-11ans, L1_SIS-ICF_mineur-12-17ans). There are also forms for continuation when a minor becomes adult and for relatives/close contacts. These documents indicate consent is obtained from participants or from parents/legal guardians for minors with age-appropriate information/assent processes.

Geography

Total Number Of Sites
39
Total Number Of Participants
2000

France

Earliest CTIS Part Ii Submission Date
18-09-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
237
Number Of Sites
39
Number Of Participants
2000

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Infectiology
Principal Investigator Name
Vincent LE MOING
Principal Investigator Email
v-le_moing@chu-montpellier.fr
Contact Person Name
Vincent LE MOING
Contact Person Email
v-le_moing@chu-montpellier.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Intensive care
Principal Investigator Name
Emmanuelle MERCIER
Principal Investigator Email
emmanuelle.mercier@chu-tours.fr
Contact Person Name
Emmanuelle MERCIER
Site Name
Centre Hospitalier De Tourcoing
Department Name
Infectiology
Principal Investigator Name
Olivier ROBINEAU
Principal Investigator Email
orobineau@ch-tourcoing.fr
Contact Person Name
Olivier ROBINEAU
Contact Person Email
orobineau@ch-tourcoing.fr
Site Name
Assistance Publique Hopitaux De Paris (Le Kremlin-Bicetre)
Department Name
Intensive care
Principal Investigator Name
Xavier MONNET
Principal Investigator Email
xavier.monnet@aphp.fr
Contact Person Name
Xavier MONNET
Contact Person Email
xavier.monnet@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Pediatric intensive care
Principal Investigator Name
Etienne JAVOUHEY
Principal Investigator Email
Etienne.javouhey@chu-lyon.fr
Contact Person Name
Etienne JAVOUHEY
Contact Person Email
Etienne.javouhey@chu-lyon.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Intensive care
Principal Investigator Name
Julie HELMS
Principal Investigator Email
julie.helm@chru-strasbourg.fr
Contact Person Name
Julie HELMS
Contact Person Email
julie.helm@chru-strasbourg.fr
Site Name
Assistance Publique Hopitaux De Paris (184 Rue Du Faubourg Saint Antoine)
Department Name
Infectiology
Principal Investigator Name
Karine LACOMBE
Principal Investigator Email
karine.lacombe2@aphp.fr
Contact Person Name
Karine LACOMBE
Contact Person Email
karine.lacombe2@aphp.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Intensive care
Principal Investigator Name
Christophe GUITTON
Principal Investigator Email
cguitton@ch-lemans.fr
Contact Person Name
Christophe GUITTON
Contact Person Email
cguitton@ch-lemans.fr
Site Name
Assistance Publique Hopitaux De Paris (27 Rue Du Faubourg Saint Jacques)
Department Name
Intensive care
Principal Investigator Name
Jean-Paul MIRA
Principal Investigator Email
jean-paul.mira@aphp.fr
Contact Person Name
Jean-Paul MIRA
Contact Person Email
jean-paul.mira@aphp.fr
Site Name
Centre Hospitalier Victor Dupouy
Department Name
Intensive care
Principal Investigator Name
Gaëtan PLANTEFEVE
Principal Investigator Email
gaetan.plantefeve@ch-argenteuil.fr
Contact Person Name
Gaëtan PLANTEFEVE
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Intensive care
Principal Investigator Name
Jean-Pierre QUENOT
Principal Investigator Email
jean-pierre.quenot@u-bourgogne.fr
Contact Person Name
Jean-Pierre QUENOT
Site Name
Assistance Publique Hopitaux De Paris (46 Rue Henri Huchard)
Department Name
Intensive care
Principal Investigator Name
Jean-François TIMSIT
Principal Investigator Email
jean-francois.timsit@aphp.fr
Contact Person Name
Jean-François TIMSIT
Contact Person Email
jean-francois.timsit@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (78 Rue Du General Leclerc)
Department Name
Pediatric intensive care
Principal Investigator Name
Pierre TISSIERES
Principal Investigator Email
pierre.tissieres@aphp.fr
Contact Person Name
Pierre TISSIERES
Contact Person Email
pierre.tissieres@aphp.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Pediatric intensive care
Principal Investigator Name
Joelle BEAUDET
Principal Investigator Email
jbeaudet@chu-reims.fr
Contact Person Name
Joelle BEAUDET
Contact Person Email
jbeaudet@chu-reims.fr
Site Name
Centre Hospitalier Departemental Vendee (Boulevard Stephane Moreau)
Department Name
Intensive care
Principal Investigator Name
Matthieu HENRY
Principal Investigator Email
matthieu.henry@ght85.fr
Contact Person Name
Matthieu HENRY
Contact Person Email
matthieu.henry@ght85.fr
Site Name
Centre Hospitalier Departemental Vendee (Boulevard Stephane Moreau)
Department Name
Infectiology
Principal Investigator Name
Thomas GUIMARD
Principal Investigator Email
thomas.guimard@ght85.fr
Contact Person Name
Thomas GUIMARD
Contact Person Email
thomas.guimard@ght85.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours (49 Boulevard Beranger)
Department Name
Pediatric intensive care
Principal Investigator Name
Julie CHANTREUIL
Principal Investigator Email
j.chantreuil@chu-tours.fr
Contact Person Name
Julie CHANTREUIL
Contact Person Email
j.chantreuil@chu-tours.fr
Site Name
Centre Hospitalier General De Bastia
Department Name
Infectiology
Principal Investigator Name
Arthur MAKA
Principal Investigator Email
arthur.maka@ch-bastia.fr
Contact Person Name
Arthur MAKA
Contact Person Email
arthur.maka@ch-bastia.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Intensive care
Principal Investigator Name
Jean REIGNIER
Principal Investigator Email
jean.reignier@chu-nantes.fr
Contact Person Name
Jean REIGNIER
Contact Person Email
jean.reignier@chu-nantes.fr
Site Name
Assistance Publique Hopitaux De Paris (51 Av Du Mal De Lattre De Tassigny)
Department Name
Intensive care
Principal Investigator Name
Armand MEKONTSO DESSAP
Principal Investigator Email
armand.dessap@aphp.fr
Contact Person Name
Armand MEKONTSO DESSAP
Contact Person Email
armand.dessap@aphp.fr
Site Name
Centre Hospitalier Sud Essonne-Dourdan-Etampes
Department Name
Intensive care
Principal Investigator Name
Shidasp SIAMI
Principal Investigator Email
ssiami@ch-sudessonne.fr
Contact Person Name
Shidasp SIAMI
Contact Person Email
ssiami@ch-sudessonne.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Intensive care
Principal Investigator Name
Mathieu LESOUHAITIER
Principal Investigator Email
Mathieu.LESOUHAITIER@chu-rennes.fr
Contact Person Name
Mathieu LESOUHAITIER
Site Name
Assistance Publique Hopitaux De Paris (2 Rue Ambroise Pare)
Department Name
Pediatric intensive care
Principal Investigator Name
Bruno MEGARBANE
Principal Investigator Email
Bruno.megarbane@lrb.aphp.fr
Contact Person Name
Bruno MEGARBANE
Contact Person Email
Bruno.megarbane@lrb.aphp.fr
Site Name
Hospices Civils De Lyon (103 Grande Rue De La Croix Rousse)
Department Name
Infectiology
Principal Investigator Name
Laurent BITKER
Principal Investigator Email
laurent.bitker@chu-lyon.fr
Contact Person Name
Laurent BITKER
Contact Person Email
laurent.bitker@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris (184 Rue Du Faubourg Saint Antoine)
Department Name
Intensive care
Principal Investigator Name
Jérémie JOFFRE
Principal Investigator Email
jeremie.joffre@aphp.fr
Contact Person Name
Jérémie JOFFRE
Contact Person Email
jeremie.joffre@aphp.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Intensive care
Principal Investigator Name
Grégoire MULLER
Principal Investigator Email
gregoire.muller@chu-orleans.fr
Contact Person Name
Grégoire MULLER
Contact Person Email
gregoire.muller@chu-orleans.fr
Site Name
Centre Hospitalier Universitaire De Nantes (1 Place Alexis Ricordeau)
Department Name
Infectiology
Principal Investigator Name
Benjamin GABORIT
Principal Investigator Email
Benjamin.GABORIT@chu-nantes.fr
Contact Person Name
Benjamin GABORIT
Contact Person Email
Benjamin.GABORIT@chu-nantes.fr
Site Name
Hospices Civils De Lyon (165 Chemin Du Grand Revoyet)
Department Name
Intensive care
Principal Investigator Name
Auguste DARGENT
Principal Investigator Email
auguste.dargent@chu-lyon.fr
Contact Person Name
Auguste DARGENT
Contact Person Email
auguste.dargent@chu-lyon.fr
Site Name
Centre Hospitalier De Haguenau
Department Name
Intensive care
Principal Investigator Name
Asaël BERGER
Principal Investigator Email
asael.berger@ch-haguenau.fr
Contact Person Name
Asaël BERGER
Contact Person Email
asael.berger@ch-haguenau.fr
Site Name
Centre Hospitalier Universitaire Reims (Rue Du General Koenig)
Department Name
Infectiology
Principal Investigator Name
Firouzé BANI SADR
Principal Investigator Email
fbanisadr@chu-reims.fr
Contact Person Name
Firouzé BANI SADR
Contact Person Email
fbanisadr@chu-reims.fr
Site Name
Les Hopitaux Universitaires De Strasbourg (1 Avenue Moliere)
Department Name
Pediatric intensive care
Principal Investigator Name
Michael LEVY
Principal Investigator Email
michael.levy@chru-strasbourg.fr
Contact Person Name
Michael LEVY
Site Name
CHRU De Nancy
Department Name
Intensive care
Principal Investigator Name
Sébastien GIBOT
Principal Investigator Email
s.gibot@chru-nancy.fr
Contact Person Name
Sébastien GIBOT
Contact Person Email
s.gibot@chru-nancy.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Intensive care
Principal Investigator Name
Julien VAIDIE
Principal Investigator Email
Julien.VAIDIE@chu-limoges.fr
Contact Person Name
Julien VAIDIE
Contact Person Email
Julien.VAIDIE@chu-limoges.fr
Site Name
Assistance Publique Hopitaux De Paris (104 Boulevard Raymond Poincare, Garches)
Department Name
Intensive care
Principal Investigator Name
Djillali ANNANE
Principal Investigator Email
djillali.annane@aphp.fr
Contact Person Name
Djillali ANNANE
Contact Person Email
djillali.annane@aphp.fr
Site Name
Centre Hospitalier Universitaire De Dijon (2 Boulevard Mal De Lattre De Tassigny)
Department Name
Infectiology
Principal Investigator Name
Lionel PIROTH
Principal Investigator Email
lionel.piroth@chu-dijon.fr
Contact Person Name
Lionel PIROTH
Contact Person Email
lionel.piroth@chu-dijon.fr
Site Name
Centre Hospitalier De Dieppe
Department Name
Intensive care
Principal Investigator Name
Pierre-Louis DECLERCQ
Principal Investigator Email
pdeclercq@ch-dieppe.fr
Contact Person Name
Pierre-Louis DECLERCQ
Contact Person Email
pdeclercq@ch-dieppe.fr
Site Name
Assistance Publique Hopitaux De Paris (104 Boulevard Raymond Poincare, Garches)
Department Name
Infectiology
Principal Investigator Name
Aurélien DINH
Principal Investigator Email
aurelien.dinh@aphp.fr
Contact Person Name
Aurélien DINH
Contact Person Email
aurelien.dinh@aphp.fr
Site Name
Centre Hospitalier De Bourg-En-Bresse
Department Name
Intensive care
Principal Investigator Name
Hela FOURATI
Principal Investigator Email
recherche-clinique@ch-bourg01.fr
Contact Person Name
Hela FOURATI
Site Name
Assistance Publique Hopitaux De Paris (78 Rue Du General Leclerc, Le Kremlin-Bicetre)
Department Name
Infectiology
Principal Investigator Name
Lélia ESCAUT
Principal Investigator Email
lelia.escaut@aphp.fr
Contact Person Name
Lélia ESCAUT
Contact Person Email
lelia.escaut@aphp.fr

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
ANAKINRA
Active Substance
ANAKINRA
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Maximum Dose
100 mg
Investigational Product Name
TOCILIZUMAB
Active Substance
TOCILIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SOLUTION FOR INTRAVENOUS INFUSION
Route
SOLUTION FOR INTRAVENOUS INFUSION
Maximum Dose
800 mg
Investigational Product Name
DALTEPARIN
Active Substance
DALTEPARIN SODIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
18000 IU
Investigational Product Name
HEPARIN
Active Substance
HEPARIN
Modality
Other
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Maximum Dose
0 IU/ml
Investigational Product Name
BARICITINIB
Active Substance
BARICITINIB
Modality
Small molecule
Routes Of Administration
ENTERAL FEEDING TUBE
Route
ENTERAL FEEDING TUBE
Maximum Dose
4 mg
Investigational Product Name
FLUDROCORTISONE
Active Substance
FLUDROCORTISONE ACETATE
Modality
Small molecule
Routes Of Administration
ORAL, NASOGASTRIC TUBE OR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE USE
Route
ORAL, NASOGASTRIC TUBE OR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE USE
Maximum Dose
50 µg
Investigational Product Name
HYDROCORTISONE
Active Substance
HYDROCORTISONE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Maximum Dose
200 mg
Investigational Product Name
OCTAPLASLG, solution pour perfusion
Active Substance
HUMAN PLASMA PROTEIN
Modality
Other
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Marketing authorisation present (authorisationCountryCode: FR, marketingAuthNumber: 34009 550 719 7 6)
Maximum Dose
12 millilitre(s)/kilogram
Investigational Product Name
INTERFERON GAMMA
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Maximum Dose
50 µg/ m2
Investigational Product Name
FILGRASTIM
Active Substance
FILGRASTIM
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Maximum Dose
5 µg/Kg

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