SHORTER trial
Research type
Research Study
Full title
A randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis
IRAS ID
317788
Contact name
Thomas P Hellyer
Contact email
Sponsor organisation
The Newcastle Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
Sepsis is a life-threating condition due to a severe infection. It is a common reason for patients to require “life-support”. Sepsis is a leading cause of death worldwide.
Antibiotics are a major part of the treatment of sepsis, but antibiotics also carry significant risks. The overuse of antibiotics promotes the emergence of “superbugs”, can also be toxic to organs such as the liver and can occasionally be responsible for life-threatening bowel infections.
Striking the right balance of using antibiotics appropriately, while avoiding their potential harm, is a challenge. Antibiotics are initiated rapidly for sepsis because of the severity of illness but once started, the exact duration needed to treat an infection adequately is unknown. Determining a duration of antibiotics that effectively treats sepsis, but is not unnecessarily prolonged, could have a big impact on antibiotic use overall.
We aim to determine whether short-duration antibiotic treatment is as good as routine practice, which is usually a longer duration of antibiotics, for critically ill patients with sepsis.
We will carry out a clinical trial including adult patients with sepsis who are admitted to a critical care unit. We will randomly allocate patients to receive a short fixed-course of antibiotics (5 days) or usual care (this is typically a 9-day course). This trial will only specify the duration of antibiotics, and the clinical team will know what duration the patient is getting. The choice or combination of antibiotics will be decided by the clinical team. All patients will have antibiotics managed according to standard antibiotic stewardship practice. The only difference between the two trial groups is that the short-duration group will have 5 days of antibiotics.
We will determine whether short-course antibiotic treatment is as effective as routine practice by assessing clinical outcomes for patients when they are in hospital and at 90-day follow-up.
REC name
Wales REC 4
REC reference
23/WA/0197
Date of REC Opinion
12 Sep 2023
REC opinion
Further Information Favourable Opinion