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ADAPT SEPSIS

Hospital ward

ADAPT-SEPSIS IS AN URGENT PUBLIC HEALTH NATIONAL CLINICAL TRIAL INVESTIGATING ANTIBIOTIC TREATMENT DURATION IN PATIENTS WITH SUSPECTED SEPSIS

Thank you for your continued support for the ADAPT-Sepsis NIHR Urgent Public Health (UPH) clinical trial through a challenging time for NHS critical care. As the numbers of new critically ill patients with COVID-19 fall across the UK, we are particularly grateful to sites that have continued patient participation throughout pandemic. 

Following planned independent review of the outcomes of the first 1000 trial patients, we are pleased to report that our Trial Steering Committee has advised us to continue patient recruitment, with the next planned checkpoint in the summer of 2021. In addition, our funder (NIHR HTA) has approved trial extension until July 2022. Therefore, we would like to take this opportunity to welcome back those sites that are currently paused from patient participation and to invite any new sites that would like to participate in ADAPT-Sepsis to get in touch with us.

As SARS-CoV-2 is becoming endemic in the UK, we want to clarify that patients with or without COVID-19 can be offered participation in the study if all other eligibility criteria are confirmed and if the patient’s treating clinical team agree.

If you would like any further information please explore our website further or get in touch with a member of the ADAPT-Sepsis trial team by email at adaptsepsistrial@warwick.ac.uk.

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

Title:

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

Summary:

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.

Duration:

4 years including follow-up

Database Access

Patients recruited: 1,262

Sites Open: 24

In the NIHR Associate Principal Investigator Scheme

Click here to view trial summary videos.

Enquiries:

Please direct all enquiries to:

Nicola McGowan - Trial Manager
Tel: 02476 151 386
Email: adaptsepsistrial@warwick.ac.uk