SHORTER Study Summary

critical care studies summaries

Protocol v4.0 12/03/2024
Rotherham Principal Investigator: Dr Susie Robinson

research topic:

Antibiotic duration for critically ill patients with suspected or confirmed sepsis

trial groups:

Intervention: 5 day course of initial antibiotic treatment for sepsis
Control: Standard of care

inclusion criteria:

Sepsis is defined as new or worsening organ dysfunction resulting from a suspected or proven infection. Patients admitted to critical care for support or monitoring of an organ dysfunction (e.g. invasive blood pressure monitoring or oxygen therapy), while treated for a suspected infection, are the population of interest.

Patients must fulfil all of the following inclusion criteria prior to randomisation:

Adult patients, aged ≥ 18, treated within a critical care setting (ICU or HDU) for suspected or confirmed sepsis due to either community- or hospital-acquired infections
Evidence of new or worsening acute organ dysfunction resulting from suspected or confirmed infection (e.g. the treatment or monitoring of an organ dysfunction)
Antibiotics initiated for suspected or confirmed sepsis and able to be randomised within 4 days of the initiation of this course of antibiotics.

exclusion criteria:

Patients must not meet any of the following exclusion criteria to be randomised:

Comorbidity with immunosuppression (e.g. Chemotherapy, maintenance steroids equivalent to >10mg/day of prednisolone, post-transplantation)
Blood neutrophil count less than 0.5 x 109 /L secondary to a pre-existing comorbidity
Infection source where usual practice involves more than 14 days of antibiotics (e.g. undrainable abscess, endocarditis, Staphylococcus aureus bacteraemia, osteomyelitis)
Receiving end-of-life care
Life-sustaining treatment expected to be withdrawn within the next 24 hours
The clinician responsible for the patient’s care is unable to adhere to the intervention

consent:

Formal consent is required for SHORTER trial. If you think your patient is in any way eligible please contact the research team (Cheryl 6060, Jake 7038, Rachael 4078) who will review the full inclusion/exclusion criteria and approach for consent.