Can interferon gamma prevent infection in critically ill patients at highest risk? A phase II randomised controlled trial - INFINIT (INterFeron to reduce INfection in InTensive care units)

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 282 人开始时间: 2023年11月10日最近更新: 2024年4月15日

试验速览

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•1. Patient has been managed in ICU for =2 days
•2. Either (a) intubated and receiving mechanical ventilation or/and (b) on both vasopressors (to control blood pressure) and renal replacement therapy
•3. Age =18 years old
•4. Informed, written consent obtained from a personal legal representative or professional legal representative
•5. Blood monocyte HLA-DR level of <8000 anti-monocyte HLA-DR antibodies per cell
•6. Negative pregnancy test in women of child bearing potential

•1. Breast-feeding or pregnancy
•2. Known history of seizures
•3. Chronic liver disease with Child-Pugh score C or worse
•4. Known allergy to interferons or latex
•5. Concomitant enrolment in another interventional trial, except where a co-enrolment agreement exists
•6. Solid organ or bone marrow transplantation
•7. Patient is under active haematological malignancy surveillance
•8. Current active systemic chemotherapy or immunotherapy for cancer (hormonal treatment will not exclude patients) known human immunodeficiency virus (HIV) with a documented CD4 count of <300 cells per cubic millilitre in the last 6 months in those not on renal replacement therapy, an estimated glomerular filtration rate <15 ml/min/1.73 metres squared
•9. Blood neutrophil count < 0.5x10^9/L
•10. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 4 times the upper limit of normal according to the recruiting hospital’s clinical reference range
•11. Known 2nd or 3rd degree heart block
•12. History of severe heart failure or history of New York Heart Association (NYHA) heart failure score of 3 or 4
•13. Proposed use of vaccines in the 10 days from randomisation
•14. Known receipt of a vaccination in the 28 days prior to admission to the ICU
•15. Consultant in charge of the patient’s care considers the patient’s participation inappropriate

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust