Hospitalised adults who have been commenced on intravenous antibiotics for sepsis Infections and Infestations Sepsis
Conditions
Interventions
As an observational study, participant involvement will be limited to sampling of blood at 4 time points over a one-week period. Blood samples will be transferred to a central laboratory. Immune pheno
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients enrolled in the ADAPT-sepsis trial. Patients are eligible if: 1. Hospitalised adult patients at least 18 years of age 2. Up to 24 hours of initiation of empiric intravenous antibiotic treatments for suspicion of sepsis 3. Likely to remain hospitalised and receiving intravenous antibiotic treatment for at least the next 72 hours 4. Requirement for critical care
Exclusion criteria
Exclusion criteria: 1. More than 24 hours since receiving first empiric intravenous antibiotic treatments for a suspicion of sepsis 2. Prolonged (greater than 21 days) antimicrobial therapy mandated (e.g. for endocarditis, cerebral/hepatic abscess, tuberculosis, osteomyelitis) 3. Severely immunocompromised (e.g. neutropenia, less than 500 neutrophils/microlitre) 4. All treatment for suspected sepsis likely to be stopped within 24 hours of its initiation because of futility 5. Consent declined 6. Previously enrolled in ADAPT-sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune phenotype measured using fluorescence-based flow cytometry of blood samples taken at ... 1. Monocyte HLA-DR 2. Neutrophil CD88 3. T cell, monocyte and neutrophil CD279 4. Percentage of regulatory T cells | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. Total duration of antibiotic treatment to 28 days following randomisation (superiority) measured in days (24-hour time periods) 2. Antibiotic dose, measured as Defined Daily Dose to 28 days 3. Unscheduled care escalation/re-admission 4. Infection relapse/recurrence requiring further antibiotic treatment 5. Super-infection, defined as new infection at a different anatomical site 6. Suspected antibiotic adverse reactions 7. Time to ‘fit’ for hospital discharge | — |
Countries
England, United Kingdom
Contacts
Public ContactTom Ewen
Outcome results
None listed