What is PRUDENCE?
The invention of antimicrobials was a major breakthrough in medical science. Antimicrobials are used to treat illness caused by bacteria. Development of these medicines meant that illnesses, like pneumonia, which were once often fatal, could now usually be successfully treated. That saved millions of lives. But effectiveness of antimicrobials is now decreasing because they are being overused. Microorganisms that are being exposed to antimicrobials change genetically over time, making it harder for the antimicrobials to work against them. As a result, “superbugs” are developing. We have no effective treatment for some of these “superbugs”. The development of resistance to antimicrobials is a major public health concern worldwide. Unhelpful, clinically unwarranted variation in care is a major contributor. Point-of-care testing that is proven to be cost-effective in clinical trials could help improve the quality of care and thus patient outcomes. This is especially true for community-acquired acute respiratory tract infections (CA-ARTI), the most common acute reasons for consulting health services in community care setting and for antimicrobial use.
The aim of PRUDENCE is to determine if having a CA-ARTI diagnostic (CA-ARTI-Dx) test result available when a clinician is considering, or plans to prescribe an antimicrobial, leads to more appropriate prescribing decisions, without causing harm to patients. PRUDENCE is a multi-country, prospective, individually randomised, platform clinical trial in community care with a nested process evaluation. The trial is a diagnostic strategy intervention study to evaluate the use of clinical algorithms that include a CA-ARTI-Dx, compared to usual clinical care without CA-ARTI-Dx.
To assess effectiveness of CA-ARTI-Dx in terms of both reductions in antimicrobial prescribing, and in terms of patient recovery.
To explore whether adding a CA-ARTI-DX to usual primary care:
- Additional effects on antimicrobial prescribing
- Effects antimicrobial use
- Effects patient recovery and safety, including complications and hospitalisation
- Effects use of medications other than antimicrobials
- Effects clinician’s decision making process regarding diagnosis and treatment
- Effects patients’ perceived ability to understand and cope with their illness
- Is cost effective
- Clinicians’ views and experiences of CA-ARTI-Dx and how they fit with/impact on delivery of care and intended future use
- Patient/parent views of CA-ARTI-Dx and how they impact consultations including patient satisfaction and intention to consult in future for similar symptoms