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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

April 1, 2026

Primary Completion Date

May 1, 2029

Study Completion Date

April 1, 2032

Conditions
Sepsis
Interventions
DRUG

Tocilizumab

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)

DRUG

Baricitinib

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)

DRUG

Anakinra

100 mg subcutaneously once daily for 10 days (or hospital discharge pending which will occur first) (same for adults and children)

DRUG

Hydrocortisone

50mg (in children: 1-2 mg/kg) IV Q6 for 7 days

DRUG

Hydrocortisone and fludrocortisone

Hydrocortisone 50mg IV Q6 for 7 days + Fludrocortisone 50mg orally or via gastric tube once a day for 7 days.

DRUG

Heparin

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).

DRUG

Low molecular weight heparin

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).

DRUG

Recombinant humanThrombomodulin( rhTM)

Recombinant human thrombomodulin (rhTM) 0.06 mg/kg/j IV, for 7 days (or ICU discharge, pending which will occur first).

DRUG

Sivelestat

0.2 mg/kg/h for 7 days (or ICU discharge, pending which will occur first)

BIOLOGICAL

Fresh frozen plasma

12 ml/kg/day as long as INR remains \>1.4

OTHER

Usual care

Usual care

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER