Personalized Immunotherapy in Sepsis

Summary

Αim of ImmunoSep is to assess whether personalized adjunctive immunotherapy directed against a state of either fulminant hyper-inflammation or immunoparalysis is able to change sepsis outcomes. Patients will be selected by a panel of biomarkers and laboratory findings and will be allocated to placebo or immunotherapy treatment according to their needs.

Timeline

Start

2021-07-29

Primary completion

2024-02-06

Completion

2024-04-27

Outcome

Met primary endpoint

paper The SOFA decrease end point was attained by 46 of 131 patients (35.1%) in the precision immunotherapy group PMID 41359996 ↗

Publications

• Giamarellos-Bourboulis EJ, Kotsaki A, Kotsamidi I, Efthymiou A, Koutsoukou V, Ehler J, Paridou A, Frantzeskaki F, Muller MCA, Pickkers P, Meylan S, Nikolopoulos I, Lupse M, Gavala A, Vlachogianni G, Solomonidi N, Alevizou A, Kondili E, Antoniadou E, Nakou M, Markou N, Hatziagelaki E, Prekates A, Komnos A, Bakkerus L, Slim MA, Dalekos GN, Karapanagiotou A, Ktena S, De Pascale G, Koulouras V, Psarrakis C, Massa E, Dakou K, Pazvanti C, Ioakeimidou A, Tsangaris I, Antonakos N, Vlaar APJ, Anisoglou S, Calandra T, Papaioannou V, Myrianthefs P, Patrani M, Alamanos I, Antonelli M, van der Meer JWM, van der Poll T, Wiersinga WJ, Ntaganou M, Gkeka E, Bauer M, Mouloudi E, Netea MG; ImmunoSep Study Group. Precision Immunotherapy to Improve Sepsis Outcomes: The ImmunoSep Randomized Clinical Trial. JAMA. 2026 Mar 3;335(9):775-786. doi: 10.1001/jama.2025.24175.
• Giamarellos-Bourboulis EJ, Dimopoulos G, Flohe S, Kotsaki A, van der Poll T, Skirecki T, Torres A, Netea MG. THE EUROPEAN SHOCK SOCIETY MEETS THE IMMUNOSEP CONSORTIUM FOR PERSONALIZED SEPSIS TREATMENT. Shock. 2023 Mar 1;59(3S Suppl 1):21-25. doi: 10.1097/SHK.0000000000001955. Epub 2022 Jul 24.
• Kotsaki A, Pickkers P, Bauer M, Calandra T, Lupse M, Wiersinga WJ, Meylan S, Bloos F, van der Poll T, Slim MA, van Mourik N, Muller MCA, van Vught L, Vlaar APJ, de Nooijer A, Bakkerus L, Weis S, Antonakos N, Netea MG, Giamarellos-Bourboulis EJ. ImmunoSep (Personalised Immunotherapy in Sepsis) international double-blind, double-dummy, placebo-controlled randomised clinical trial: study protocol. BMJ Open. 2022 Dec 20;12(12):e067251. doi: 10.1136/bmjopen-2022-067251.

Drugs

Indications