THRILL: Treat Hyperinflammation in child oncology study - A single arm, historically controlled, open label phase II study on the efficacy and safety of the recombinant interleukin (IL)-1R antagonist anakinra in pediatric cancer patients admitted to the intensive care with sepsis and signs of hyperinflammation

Condition studied

Sepsis, Hyperinflammation

Investigational medicinal product(s)

Eligibility

Primary endpoint

The difference in 28-day all-cause mortality between the early anakinra + SoC and historical SoC group.

Endpoint detail

Adverse events (AEs), as characterized by type, frequency, severity (as graded using CTCAE v5.0), ≥ grade 3 liver enzyme abnormalities (ALT, bilirubin), The cumulative incidence of secondary infections., The difference in cumulative Phoenix-8 organ dysfunction score over three days between the early anakinra + SoC and historical SoC group., The difference in cumulative Phoenix-8 organ dysfunction score over seven days between the early anakinra + SoC and historical SoC group., The difference in ICU mortality between the early anakinra + SoC and historical SoC group., The comparison of the two groups of treatment on: - the number of ventilator-free days at day 28 - the number of vasoactive medication-free days at day 28 - the highest VIS score - the cumulative VIS score over seven days - the requirement of CRRT - the requirement of ECMO, The comparison of the two groups of treatment on ICU LOS.