Sepsis Infections and Infestations
Conditions
Interventions
Intervention 1:- Diagnostic Trial
Research Question:- Do rapid PCR-based microbiological diagnostics combined with procalcitonin improve outcomes and antibiotic stewardship compared to standard care i
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (=16 years of age) admitted to ICU due to suspected sepsis and expected to stay for at least two calendar days (i.e. expected to still to be in ICU the day after tomorrow). 2. Receiving intravenous antibiotics for suspected sepsis 3. According to local clinical judgement, patient has received adequate initial early fluid resuscitation The following inclusion are for intervention 3 only (can be after initial trial entry): 1. Intubated and mechanically ventilated and expected to continue for another 24 hours 2. Or requiring two organ support (i.e. vasopressors or renal replacement therapy) 3. An absolute lymphocyte count 1.2 x10^9 /L in between.
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 16/07/2026: 1. More than 24 hours since ICU admission (this does NOT apply for trial 3, GM-CSF). Note: As early intervention in sepsis is important, the aim should be to enrol eligible patients as soon after ICU admission as is practically possible. 2. Previously admitted to ICU due to sepsis on this hospital admission 3. Not expected to survive initial resuscitation (24 hours) 4. Neutropaenia (50 x10^9 /L 4. Allergy or previous adverse reaction to GM-CSF 5. Known to be pregnant or breastfeeding 6. Known recent (required treatment within the last 5 years) haematological malignancy 7. Solid organ or bone marrow transplantation 8. Patient weight >125kg 9. Known anaphylaxis to GM-CSF or yeast-derived products Previous key exclusion criteria: 1. More than 24 hours since ICU admission (this does NOT apply for trial 3, GM-CSF). Note: As early intervention in sepsis is important, the aim should be to enrol eligible patients as soon after ICU admission as is practically possible. 2. Previously admitted to ICU due to sepsis on this hospital admission 3. Not expected to survive 90 days, due to pre-existing chronic (end-stage) disease 4. Not expected to survive initial resuscitation (24 hours) 5. Neutropaenia (50 x10^9 /L 4. Allergy or previous adverse reaction to GM-CSF 5. Known to be pregnant or breastfeeding 6. Known recent (required treatment within the last 5 years) haematological malignancy 7. Solid organ or bone marrow transplantation 8. Patient weight >125kg 9. Known anaphylaxis to GM-CSF or yeast-derived products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day mortality combined with clinical state (in-hospital with organ support, in-hospital without organ support, discharged from hospital) over time | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of mechanical ventilation, shock, renal replacement therapy up to 90 days 2. Length of stay in ICU and hospital up to 90 days 3. Antibiotic use (defined daily doses per 1000 occupied bed days) up to 90 days 4. Infection relapse / recurrence or secondary infection requiring further antibiotic treatment up to 90 days 5. Adverse events and adverse drug reactions (including antibiotic related adverse events) up to 90 days 6. Health-related Quality of Life (EQ-5D-5L) and cognitive function (MoCA-Blind) at 6 months 7. 1-year mortality | — |
Countries
England, United Kingdom
Outcome results
None listed