PRocess Evaluation of the ADAPT-Sepsis trial (PREADAPT-Sepsis)
Research type
Research Study
Full title
PRocess Evaluation of the ADAPT-Sepsis trial (PREADAPT-Sepsis): Factors influencing implementation of biomarker guidance for antibiotic prescribing decisions in sepsis
IRAS ID
232570
Contact name
Ruth Louise Poole
Contact email
Sponsor organisation
Cardiff & Vale University Health Board
Clinicaltrials.gov Identifier
RX127, NICE Project Reference (MTEP); researchregistry4244, ResearchRegistry.com; CED113, Cedar reference
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Procalcitonin and C-reactive protein are biomarkers (natural indicators of illness) found in the blood of people exposed to bacterial infection. Levels are high in people with severe infection (sepsis), but reduce with effective antibiotic treatment. Testing biomarker levels may help to guide the length of antibiotic treatment needed. The prescribed duration needs to be long enough to treat the infection, but if treatment is prolonged it could contribute to the development of antimicrobial resistance (which reduces the effectiveness of antibiotics). A randomised controlled trial (ADAPT-Sepsis) will find out whether using biomarkers to guide antibiotic duration is effective and safe for patients when compared with standard care. Plans for the trial are detailed in a separate protocol.
The trial will identify which intervention (if any) was most effective. A process evaluation is a research method which adds information to help understand why a complex intervention was effective or not, and why it may have different outcomes in varying circumstances. PREADAPT-Sepsis is a process evaluation which will find out extra information from the hospitals and staff involved in the ADAPT-Sepsis trial. It aims to find out what factors influence antibiotic prescribing decisions, and what role biomarkers play. Trial staff will be invited to complete questionnaires and to participate in interviews.
At the end of the study, the results of the trial will be combined with the process evaluation findings. In this way we can find out whether there is a relationship between how the tests are used in practice, and length of antibiotic treatment. The overall results will also help us to understand which type of test is most effective, and what approaches can be taken by NHS teams to successfully implement biomarker testing within their local settings.REC name
N/A
REC reference
N/A