Sepsis Infections and Infestations Sepsis, unspecified
Conditions
Interventions
In-patients receiving Critical Care treatment will be randomised (web-based randomisation) to one of two intervention groups (C-Reactive Protein (CRP) or Procalcitonin (PCT)) guided antibiotic duratio
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalised adult patients at least 18 years of age 2. Up to 24 hours of initiation of empiric intravenous antibiotic treatments for a suspicion of sepsis (i.e. “suspected sepsis” – see trial definition below) 3. Likely to remain hospitalised and receiving intravenous antibiotic treatment for at least the next 72 hours 4. Requirement for critical care Suspected sepsis definition: Within the context of this study, ‘suspected sepsis’ is defined as ‘acute organ dysfunction associated with suspected infection’ (1). The trialists do not mandate a definition for ‘acute organ dysfunction’ and patient information underpinning local clinical decisions will be captured as part of the Case Report Form (CRF) which will include the Sequential Organ Failure Assessment (SOFA) score.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 05/02/2021: 1. More than 24 h 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/µl) 4. All treatment for suspected sepsis likely to be stopped within 24 hours of its initiation because of futility 5. 5. Any patient given, or anticipated to receive an IL-6 receptor inhibitor drug (e.g. tocilizumab or sarilumab) during their acute hospital admission 6. Consent declined 7. Previously enrolled in this trial _____ Previous exclusion criteria: 1. More than 24 h 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/µl) 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 this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary clinical effectiveness outcome: total duration of antibiotic treatment to 28 days following randomisation (superiority) measured in days (24-hour time periods from randomisation) 2. Primary safety outcome: 28-day all-cause mortality (non-inferiority) following randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary effectiveness and safety outcome measures to 28 days following randomisation: 1. Antibiotic dose, measured as Defined Daily Dose 2. Unscheduled care escalation/re-admission 3. Infection relapse/recurrence requiring further antibiotic treatment 4. Super-infection, defined as new infection at a different anatomical site 5. Suspected antibiotic adverse reactions 6. Time to ‘fit’ for hospital discharge | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed