Can a drug with the potential to boost the immune system (interferon gamma) prevent infection in patients who are critically ill and at particularly high risk of developing new infections during their stay in an intensive care unit?

Phase 2

• Conditions: Critically ill patients in intensive care units who are at particularly high risk of secondary (hospital-acquired) infection; Infections and Infestations

• Registration Number: ISRCTN10449048
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-10
• Last Update Posted: 15 April 2024
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified