A trial comparing short course antibiotics and standard course antibiotics for the treatment of sepsis
- Conditions
- SepsisInfections and Infestations
- Registration Number
- ISRCTN40090372
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 2244
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.
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 Life-sustaining treatment expected to be withdrawn within the next 24 hours.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method