Scotland: Biomarker-guided duration of antibiotic treatment for sepsis
Research type
Research Study
Full title
Biomarker-guided duration of antibiotic treatment in hospitalised patients with suspected sepsis. The ADAPT-Sepsis Trial.
IRAS ID
234179
Contact name
Paul Dark
Contact email
Sponsor organisation
University of Manchester
ISRCTN Number
ISRCTN47473244
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Sepsis is a common life-threatening condition that is triggered by infection. In sepsis, the body’s defense mechanisms (immune system) react excessively, resulting in widespread inflammation and swelling. If not treated quickly, sepsis can result in shutdown of vital organs which can result in death. Each year in the UK, about 200,000 people develop sepsis and up to a quarter will die. Previous research indicate that early recognition of sepsis and rapid antibiotic treatments are the most important factors for patient survival. While starting antibiotics for sepsis is crucial, the recommended duration of such treatment is uncertain. The lack of research on when to stop treatment safely can lead to an overuse of antibiotics in this condition. Antibiotic overuse is important because it promotes bacteria that are resistant to antibiotics (antimicrobial resistance), which means that sepsis and, indeed, other infections would become difficult to treat in the future. Shorter courses of antibiotics for a patient with sepsis, if given appropriately, may result in less antibiotic use resulting in fewer side effects, less risk of antibiotic resistance and a reduction in costs. Chemicals circulating in the blood can indicate the level of an infection and how effective the treatment of an infection is. These chemicals are called biomarkers. The two most well researched circulating biomarkers in sepsis are C-reactive protein (CRP) and procalcitonin (PCT). They are both protein chemicals produced by the human body in response to infection and can be readily measured in blood samples using NHS laboratory equipment.
The aim of this study is to find out whether the duration of antibiotic treatment given to patients with sepsis can be safely reduced following the close daily monitoring of these biomarkers. Patients will have blood samples taken daily whilst receiving antibiotic treatment (typically 7 days), follow-up at 28 & 90 days.
REC name
Scotland A: Adults with Incapacity only
REC reference
17/SS/0125
Date of REC Opinion
4 Dec 2017
REC opinion
Favourable Opinion