PROTECT

Platform Randomised evaluation of clinical Outcomes using novel TEChnologies to optimise antimicrobial Therapy.

Background

Antibiotic resistance is where bacteria that cause infections become resistant to antibiotics. It could threaten the lives of millions of people around the world if urgent action is not taken. To prevent this problem the use of antibiotics should be limited to only those patients who absolutely need it. When patients present to emergency care with a suspected infection, it is difficult for healthcare professionals to know if it is caused by a bacteria (which needs treating with antibiotics) or a virus (which cannot be treated with antibiotics). There is no test which can confirm bacterial infection, and current laboratory tests take 24-48 hours to give results.

Sepsis misdiagnosis

Healthcare professionals worry about missing a diagnosis of sepsis, which is a common, potentially life-threatening complication of infection. The best treatment for sepsis includes early recognition, and prompt antibiotics and fluids delivered by a drip into a vein. The lack of a perfect test for bacterial infection, and the concern about delaying treatment for possible sepsis, has led to prescribing too many antibiotics.

There are new technologies which may help clinicians make decisions about whether to start, stop or change antibiotics, but they have never been evaluated in a large trial that allows multiple technologies to be evaluated, alone or in combination, wherever patients are seen with suspected infection.  This form of study is called a platform trial.

The Covid-19 pandemic showed that new treatments can quickly and safely be brought into clinical use by conducting these platform trials, which allow faster decisions about which new treatments and tests should be used routinely, and improve patient safety.

Study aim

The aim of PROTECT is to assemble a multidisciplinary team of researchers who can plan and prepare a well-designed platform trial, that allows multiple technologies to be evaluated rapidly, and then to be adopted quickly into care to benefit patients. We need to show that these technologies are safe for patients, improve care, and reduce the use of unnecessary antibiotics.

We will identify which technologies should be tested, and when they could be best used to guide decisions about antibiotic use, and seek views of patients, carers and healthcare professionals about the acceptability of using these technologies in routine care, and which outcomes matter to them. In November 2023, we will a submit proposal for a full study for the research funder.

Patient and public involvement

We have three public involvement co-applicants, and will seek support from Antibiotic Research UK, who will connect us to a wider PPI group. Our public involvement co-applicants have experience of either themselves or a relative being treated for serious infection, but we will provide further training to them about the technologies and care pathways. As part of preparing for the platform trial, we will engage in a wide consultation on the study design, patient acceptability, patient perceptions of antibiotic therapy in management of bacterial infections, and the risks of antibiotic resistance.