Sepsis Infections and Infestations
Conditions
Interventions
Current interventions as of 06/11/2025:
Patients will be randomised to one of two arms
the intervention arm and the comparator arm.
Participants randomised to the intervention arm will have the duration of antibiotics adjusted to a 5-day course. This duration commences from the initiati
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 06/11/2025: 1. Adult patients, aged >=18 years, treated within a critical care setting (ICU or HDU) for suspected or confirmed sepsis due to either community- or hospital-acquired infections. 2. Evidence of new or worsening acute organ dysfunction resulting from suspected or confirmed infection (e.g. the treatment or monitoring of an organ dysfunction). 3. Antibiotics initiated for suspected or confirmed sepsis, patient is still receiving antibiotics at randomisation, and is able to be randomised within 4 days of the initiation of this course of antibiotics. Process evaluation: Clinical staff involved in everyday prescribing and/or managing of antibiotics within critical care. _____ Previous key inclusion criteria: 1. Adult patients, age >=18 years, treated within a critical care setting (ICU or HDU) for suspected or confirmed sepsis due to either community- or hospital-acquired infections. 2. Evidence of new or worsening acute organ dysfunction resulting from suspected or confirmed infection (e.g. the treatment or monitoring of an organ dysfunction). 3. Antibiotics initiated for suspected or confirmed sepsis and able to be randomised within 4 days of the initiation of this course of antibiotics Process evaluation: Clinical staff involved in everyday prescribing and/or managing of antibiotics within critical care.
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 06/11/2025: 1. Comorbidity with immunosuppression (e.g. Chemotherapy, maintenance steroids equivalent to > 10mg/day of prednisolone, post-transplantation). 2. Blood neutrophil count less than 0.5 x 10^9/L secondary to a pre-existing comorbidity. 3. Infection source where usual practice involves more than 14 days of antibiotics (e.g. undrainable abscess, endocarditis, Staphylococcus aureus bacteraemia, osteomyelitis). 4. Receiving end-of-life care. 5. Life-sustaining treatment expected to be withdrawn within the next 24 hours. 6. The clinician responsible for the patient’s care is unable to adhere to the intervention. 7. Concomitant enrolment in another interventional trial, except where a co-enrolment agreement with SHORTER exists. _____ Previous key exclusion criteria: 1. Comorbidity with immunosuppression (e.g. Chemotherapy, maintenance steroids equivalent to > 10mg/day of prednisolone, post-transplantation) 2. Blood neutrophil count less than 0.5 x 10^9/L secondary to a pre-existing comorbidity 3. Infection source where usual practice involves more than 14 days of antibiotics (e.g. undrainable abscess, endocarditis, Staphylococcus aureus bacteraemia, osteomyelitis) 4. Receiving end-of-life care 5. Life-sustaining treatment expected to be withdrawn within the next 24 hours. 6. The clinician responsible for the patient’s care is unable to adhere to the intervention. The following participant exclusion criteria was added on 03/03/2025: 7. Concomitant enrolment in another interventional trial, except where a co-enrolment agreement with SHORTER exists (a list of interventional trials approved for co-enrolment can be found on the trial website: https://www.shortertrial.com/).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. 28-day all-cause mortality (non-inferiority safety outcome) 2. Total antibiotic treatment days measured at 28 days (superiority clinical effectiveness outcome) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/11/2025: 1. All-cause mortality measured at 90 days 2. Suspected clinically relevant antibiotic-associated adverse events during index hospital admission occurring from randomisation up to hospital discharge 3. Length (number of days) of critical care unit stay for the initial index episode of sepsis measured up to 90 days 4. Length (number of days) of hospital stay measured up to 90 days 5. Number of further/recurrence of infections requiring additional antibiotic courses following the index sepsis episode, measured up to 28 days 6. Occurrence of readmission to critical care or hospital during the 90 day follow up period 7. Incremental cost per death avoided at 90 days measured using mortality data and the Health Resource Usage & Time and Travel Questionnaire 8. Incremental cost per Quality Adjusted Life Year (QALY) gained at 90 days measured using the EQ-5D-5L questionnaire 9. Cost-effectiveness acceptability curves (CEACs) to assess the probability of the intervention being considered cost-effective at different willingness-to-pay (WTP) thresholds for a gained QALY at 90 days measured using the EQ-5D-5L and Health Resource Usage & Time and Travel Questionnaires 10. Average healthcare costs per participant over 90 days for each area of resource use measured using the Health Resource Usage & Time and Travel Questionnaire 11. Utility scores derived from responses to the EQ-5D-5L questionnaire at 90 days 12. Average QALYs per participant at 90 days measured using the EQ-5D-5L questionnaire 13. Incremental cost per QALY gained over the patient’s lifetime measured using the EQ-5D-5L questionnaire 14. Cost-effectiveness acceptability curves (CEACs) to assess the probability of the intervention being considered cost-effective at different willingness-to-pay (WTP) thresholds for a gained QALY over the participants lifetime measured using the EQ-5D-5L and Health Resource Usage & Time and Travel Questionnaires _____ Previous s | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed