PRUDENCE
Research type
Research Study
Full title
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
IRAS ID
285877
Contact name
N/A CTRG
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
ISRCTN Number
ISRCTN13336322
Duration of Study in the UK
2 years, 2 months, 28 days
Research summary
The discovery of antibiotics was a major breakthrough in medical science. Antibiotics are used to treat illness caused by bacteria. Development of these medicines meant that illnesses, like pneumonia, which were once often fatal, could be successfully treated, saving millions of lives. But their effectiveness has decreased because they are misused. Highly resistant ‘superbugs’ have appeared against which we have no effective treatment. The development of antibiotic resistance is now a major public health concern worldwide.
Bacteria that are exposed to insufficient antibiotic can change and become resistant to their killing effects. Another cause of resistance is when antibiotics are prescribed when there is no evidence to prove which micro-organism is causing a patient’s symptoms. Clinical studies have shown that confirming a patient is more likely to be infected with a bacterium (or not) before prescribing an antibiotic by using a point-of-care test in a doctor’s surgery could help improve the quality of patient care and aid recovery. This is especially true for community-acquired acute respiratory tract infections (CA-ARTI), the commonest reasons for consulting health services in the community and for antibiotic use.
The aim of PRUDENCE is to determine if there is added value provided by having a CA-ARTI diagnostic (CA-ARTI-Dx) test done in the surgery to give a quick result. Then the result is available when a clinician is considering, or plans to prescribe an antibiotic, which could lead to more appropriate prescribing decisions, without causing harm to patients.
The study will be a pragmatic, platform, randomised controlled trial of point-of-care diagnostics, evaluated over two seasons of increased community acquired acute respiratory tract infections, in up to 10 European countries starting in January 2021.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0385
Date of REC Opinion
17 Nov 2020
REC opinion
Further Information Favourable Opinion