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 - POCT), could help identify patients that will and will not benefit from antibiotic treatment, and lead to better use of these medicines. This is true especially for community-acquired acute respiratory tract infections, such as sore throat or cough, the commonest acute reasons for antibiotics use in community care.
The 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) trial ran from March 2019 to September 2024 and included two main networks: the primary care network coordinated by the University of Oxford and the long-term care facility (LTCF) network coordinated by the ID-CARE team at the University of Verona.
It was a multi-country, prospective, pragmatic, platform randomised controlled trial of point-of-care diagnostics including a follow-up period of 28 days and, for some patients, an intensive sampling substudy. Prudence was funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 820755 and was sponsored by the University of Oxford. The trial aim was to test whether having a diagnostic test result available, when health care professions make a decision about antibiotic prescribing, results in fewer antibiotics being prescribed without harming patients.
The trial met and exceeded the recruitment target with a total of 2649 participants recruited in totals from the following countries: the UK, Greece, Georgia, Ireland, Poland, Germany, Belgium, Hungary, Spain, France, Italy, Switzerland, and Israel. The trial results will soon be published.
Key outcomes of interest included assessment of the effectiveness of CA-ARTI diagnosis (CA-ARTI-DX) in reducing both antibiotic prescription and time to patient recovery. Secondary outcomes included: explore whether adding a CA-ARTI-DX to usual primary care has additional effects on antibiotic prescription, patient recovery and safety, the use of medications other than antibiotics, clinician’s decision as well as effects on patients’ perceived ability to understand and cope with their illness and cost effectivness.
This trial was part of a larger project, VALUE-Dx (820755), studying the value of diagnostics to combat antimicrobial resistance by optimising antibiotic use - and made 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.
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