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Clarification around when to move from intervention to follow up phase of trial

ADAPT protocol published

by the Journal of the Intensive Care Society.

RISC Sepsis protocol published Link opens in a new window

by BMJ open


Professor Dark discusses the lack of evidence surrounding procalcitonin testing for diagnosing and monitoring sepsis and CRP monitoring. He outlines the ADAPT-Sepsis trial, it's relevance in COVID-19 and outcomes.

Key information


BiomArker-guided Duration of Antibiotic treatment in hospitalised PaTients with suspected Sepsis: the ADAPT-Sepsis Trial

Chief Investigator: Professor Paul Dark

Sponsor: University of Manchester

Funder: Commissioned by NIHR Health Technology Assessment Programme

Registration Number: ISRCTN47473244


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 indicates 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.

Sample size:

2760 - patients will be randomised across the 3 arms using a ratio of 1:1:1

Primary outcome:

The primary objective of this trial is to determine whether treatment protocols based on monitoring CRP or PCT in hospitalised adult patients with suspected sepsis reduces the duration of antibiotic therapy (superiority) while maintaining treatment safety (non-inferiority) as measured by 28-day mortality.


6 years including follow-up

Database AccessLink opens in a new window

Click here to view trial summary videos

Patients recruited: 2,738

Sites Open: 28

NIHR Associate Principal Investigator Scheme

Uzma Manazar - Trial Manager

Tel: 02476 151 072