A-Stop2

Antifungals - Stopping Early with a Fungal Biomarker-based Stewardship Algorithm in Critical Care

OUR AIM: In response to the antimicrobial resistance commissioning brief, we plan to carry out a large study of patients on intensive care units (ICUs), to see whether new blood tests used to diagnose a particular type of infection, called fungal infection, leads to more tailored treatment of patients.  

BACKGROUND Patients in ICU are frequently prescribed treatment for fungal infection (called antifungal treatment) when doctors suspect that they may have a serious fungal infection. Currently used lab tests are slow, taking up to five days for the results. Delays to starting treatment increases the risk of patients dying, therefore, doctors tend to take a cautious approach by starting treatment before these results are available. This means that up to 95% of patients who receive antifungal treatment do not need it. This treatment can have side effects, is expensive, and its over-use leads to resistance to these medicines making them less effective when they are needed most. So, it would be best if we could avoid giving treatment to patients who do not need it. We wish to trial new rapid tests (taking around 1 day) that are not widely used in the NHS currently, because of uncertainty in whether they would change a patient’s treatment and whether they are good value-for-money. In a recent study, we have been evaluating four of these new tests. We propose to take forward two of these that have been found to reliably rule out infection when used in addition to standard care tests to assess whether their use safely reduces unnecessary antifungal treatment.  

HOW WE WILL DO THE STUDY: We plan to recruit 1226 patients on ICUs who have recently been started on antifungal treatment because of concern that they may have infection. Half of the patients will have the new tests carried out on a blood sample in addition to receiving usual care and the other half will continue to receive only usual care. The test result will be used to provide advice to the clinical team about whether to stop treatment. To ensure patient wellbeing, the final decision to stop antifungal therapy will rest entirely with the clinical team. We will assess the effectiveness of the new tests using two key outcomes. These are the total number of days antifungal treatment given (until Day 28) and the proportion of patients alive after 28 days.  

PATIENT AND PUBLIC INVOLVEMENT (PPI): We have worked closely with patients and the public to develop this study. We presented the study to a PPI group who focus on intensive care research and received positive feedback on the importance of the topic, our approach to consent and the importance to patients of study outcomes. Two PPI representatives have joined the research team and enthusiastically support the study: one (KY) is a previous chair of the Intensive Care Society Patients and Relatives Committee with substantial previous experience of contributing to clinical trials as a PPI rep; the other (CK) has lived experience of having close relatives in intensive care receiving treatment for infection. Input from CK and the PPI focus group added two secondary outcomes.  

DISSEMINATION: We will use infographics, social media, our PPI groups and existing networks to help us tell people about the study and its results. We will present at scientific conferences and publish the results in medical journals. We will tell those who write NHS guidelines about the study findings to ensure that it guides the care of patients in the future. 

1226

Primary Effectiveness: Total duration (days) of antifungal treatment from randomisation to 28 days