PRUDENCE: Platform Randomised controlled trial of point of care Diagnostics for Enhancing the quality of aNtibiotic prescribing for Community acquired acute respiratory tract infection in ambulatory care in Europe

Using antibiotics too often and for the wrong illness increases antibiotic resistance. The effectiveness of antibiotics is now decreasing because they are being overused. The development of resistance to antibiotics is a major public health concern worldwide. Diagnostic tests used when a patient first visits their doctor (point of care diagnostic tests), could help identify patients that will and will not benefit from antibiotic treatment, and lead to better use of the precious medicines. This is especially true for community-acquired acute respiratory tract infections (CA-ARTI), such as sore throat or cough, the commonest acute reasons for antibiotics use in community care.

The aim of the PRUDENCE Trial is to find out whether having a diagnostic test result available for community-acquired acute respiratory tract infections, such as sore throat or cough, when health care professions make a decision about antibiotic prescribing, leads to more appropriate prescribing decisions without causing harm to patients. The trial will run in community care, including doctor’s surgeries, paediatric centres or long-term care homes, in several countries and will last for about two years. We hope the results will improve care.

In the UK, patients will be recruited through primary care centres selected as the trial's investigating sites and randomly allocated to receive either usual care or a diagnostics intervention. The trial aims to recruit approximately 2500 participants across European study sites.

Study Design: Pragmatic, platform, randomised controlled trial of point-of-care diagnostics

Sponsor: University of Oxford

Ethics Ref: 20/NW/0385  

Contact: valuedx@phc.ox.ac.uk

This trial is part of a larger project, VALUE-Dx, studying the value of diagnostics to combat antimicrobial resistance by optimising antibiotic use - and makes up part of the clinical Work Package Four (WP4). The aim of Value-Dx is to transform clinical practice, improve patient outcomes, and combat antimicrobial resistance (AMR), through the widespread use of clinical and cost-effective innovative diagnostics strategies to achieve more personalised evidence-based antibiotic prescription and use in community care settings. Homepage - value-dx 

Project dates: 01 March 2019 to 30 June 2024