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Trial Overview

What is the purpose of the study?

Sepsis is a condition that results from potentially serious infections. If a patient has sepsis, their body’s defence mechanisms (or ‘immune system’) may react excessively and fail. We know that treatment using antibiotics, started as early as possible, is essential. Antibiotics are very effective at treating infections and the care team looking after you are very skilled at recognising infection and selecting appropriate treatments which will include antibiotics.

While starting antibiotics to combat sepsis is crucial it is less clear when this treatment can safely stop. The lack of research on when to stop treatment safely may be leading to an overuse of antibiotics. Antibiotic overuse is becoming a problem because it promotes bacteria that are resistant to antibiotics (so-called 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, may result in reducing the risk of antibiotic resistance, with fewer side effects (all medicines including antibiotics may cause side effects in some patients) and reduced costs.

What are Biomarkers and why could these be important?

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 biomarkers in sepsis are ‘C-reactive protein’ (CRP) and ‘procalcitonin’ (PCT). They are both chemicals produced by the human body in response to infection and they can be easily measured in blood samples using NHS laboratory equipment. A number of studies around the world have shown that high levels of both CRP and PCT in the blood of patients with sepsis fall when antibiotics are given and the infection is reduced. Our proposed research is to determine if the duration of antibiotic treatment given to patients with sepsis can be safely reduced if these biomarkers are closely monitored every day.

Who can take part in the study?

Adults in ICU aged 18 and older being treated with antibiotics for sepsis or possible sepsis as part of their hospital treatment.

The proposed research will offer 2760 patients with sepsis in up to 48 different hospitals an opportunity to take part.

What happens to the patients taking part in the study?

Their stay in hospital will continue as normal. The study seeks to test and compare 3 possible treatment protocols:

(1) a standard course of antibiotics (usually about 7 days),

Or treatment courses based on the addition of either:

(2) Daily CRP measurement;

(3) Daily PCT measurement.

Participants taking part will be allocated to one of these groups at random. One extra daily blood sample will be taken from them, on each day that they continue receiving antibiotic treatments. This additional blood sample is approximately equal to 1 teaspoon of blood (5mls). The blood samples will be disposed of after use using standard lab procedures. The research blood sample will not be taken if the clinicians feel that it is not safe to do so. The biomarker measurements will be performed from each daily blood sample. The results will help provide advice to the doctors about when to stop antibiotics. To assure patient safety, the final decision to stop antibiotics will always rest entirely with the doctor.

To make sure the study provides the best evidence for the NHS, participants or the treating team will not know which study group the participant have been assigned to, the doctors will receive daily written advice to help their decision to stop antibiotics safely.

Random selection of the Group

If the participant decides to take part, it will not be possible for them to choose which one of the 3 groups they are in. It is important that this is decided by a process of random selection. There is an equal chance of you being selected for any one of the 3 groups. The group will not be confirmed to you or your clinical team, this is known as blinding. This is done to ensure that the decisions of the team treating you are not influenced until more is known about the daily monitoring of biomarkers. In order to maintain the blinding the additional research blood sample will be taken from all patients taking part in this study. The lab will not analyse the sample if you have been allocated to the control group, it will be disposed of using standard lab procedures.

Follow-up & Medical Information

In addition to the daily blood samples that will be taken whilst the participant are receiving antibiotic treatment, we would like to collect some additional information from the medical notes. The hospital research team, will do this in a standardised way for 28 days. If the participant is transferred to another hospital within this time the hospital research team would contact that hospital and/or if the patient is discharged to the community within this 28 days, they would do this by either accessing NHS records, contacting their GP, or they may also wish to contact the participant or their nominated contact at 28 days. We would also like to follow their journey as a patient and collect more medical information 90 days after they decided to join the study. This will be done centrally through linked medical records.

Patient Confidentiality

Any information collected during the study will be kept strictly confidential, anonymised where possible and will only be used for research purposes. Data protection regulations will be strictly adhered to.

What are the possible disadvantages or risks in taking part?

It is not expected that any patients will come to harm whilst participating in this study. In most cases the additional research blood sampling can be taken from an arterial or venous tube (cannula) which is already in place as part of standard care. In exceptional cases, blood sampling for both routine clinical care and the blood for research will be from a vein using a needle. There may be a sharp scratch when the needle is inserted and possible bruising from the area from which the blood was taken.

Two independent Monitoring Committees will scrutinise the progress of the study. The study will run over 3 years to allow enough NHS patients throughout the UK to take part. This will ensure that there is confidence in the results, in order to make recommendations regarding the duration of antibiotic treatment for sepsis.

Trial News

Trial Summary Video

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Please direct all enquiries to:

Uzma Manazar - Trial Manager
Tel: 02476 151 072