A randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis
Sepsis
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 initiation of antibiotics. This short course of antibiotics relates only to the initial course of antibiotics and to its duration. The choice of antibiotics will be according to the clinical team. Duration of antibiotics in the comparator arm will be according to best practice and guidelines as per standard care. All other aspects of care between the two trial groups will be according to best practice, including antibiotic adjustments according to test results and antibiotic stewardship multi-disciplinary team involvement. Participant follow up will extend to 90-days. Outcome data will be collected from clinical records and routinely collected electronic data including Intensive Care audit bodies such as Intensive Care National Audit & Research Centre (ICNARC). The majority of outcome data will be collected before participants are discharged from hospital. Participants will be asked to complete questionnaires for health economic analysis (quality of life, time and travel) at 90 days. Participants will be contacted by telephone or post if discharged by this point. In summary, patients will be screened for eligibility and have antibiotic duration for sepsis adjusted if randomised to the intervention arm. All other aspects of routine care will be unchanged. Participants will be followed up for 90 days following randomisation. The majority of outcome data will be collected from clinical records or routine electronic data sources. Participants will be asked to complete questionnaires at 90-day follow up for health economic analysis. Process Evaluation: We will utilise mixed methods, using purposive sampled qualitative data together with quantitative data from the trial. Data will be collect
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.
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/).