Study Detail

ADAPT-Sepsis Trial

BiomArker-guided Duration of Antibiotic treatment in hospitalised PaTients with suspected Sepsis (ADAPT-Sepsis Trial)

Status: Open

Type: Interventional

Funder: NIHR

Sponsor: University of Manchester

CI: Prof Paul Dark

IRAS-Number: 209815

CPMS-ID: 35421

Approval Date: 19 October 2020

Description:

Sepsis is a common life-threatening condition that is triggered by infection. In sepsis, the body's defence 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.

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