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 Aim
The aim of PRUDENCE is to determine if there is added value provided by having a point-of-care diagnostic test done in the surgery to give a quick result. 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.
Contact Details
Funding Details
Innovative Medicines Initiative 2 Joint Undertaking
Project end date: 30th September 2024
The PRUDENCE Trial is part of the VALUE-Dx project, which you can find out about here.
Background and Study Aims
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, such as sore throat or cough, the commonest acute reasons for antibiotics use in community care.
The PRUDENCE Trial will 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.
Who can participate?
To take part, you need to have a cough, which started less than 28 days ago, or sore throat, which started less than 14 days ago. Your GP will also be considering or planning to prescribe an antibiotics for your symptoms.
What are the possible risks and benefits of participating?
Risks: If you are randomized to usual care plus a diagnostic test, a biological sample will be taken. Depending on what type of sample, some discomfort may be felt. The consultation may take longer than it would normally take without a diagnostic test.
Benefits: By participating in this study you may not personally benefit but you will help doctors learn more about which diagnostic tests could help them make better decisions when treating people with cough or sore throat. You will be helping with research that may lead to a more personalised approach to antibiotic prescribing, one that better targets antibiotics to patients who are likely to benefit, and directs alternative, non-antibiotics treatments to patients who are unlikely to benefit.
What does the study involve?
If you are randomised to the diagnostic test group, a member of the clinical team will take a sample from you. This could be a swab (a small bit of cotton wool on a stick) from your nose or mouth, or a pinprick of blood from your finger.
The clinical team member will perform the diagnostic test, which varies according to the nature of the test but is usually no more than 20 minutes.
You will be asked to complete a paper or online diary for 14 days starting on the day you consulted with your doctor for this illness. The diary will include questions about your illness, recovery, healthcare use, out- of-pocket expenditure, time off work or school, quality of life, satisfaction with the initial consultation, beliefs about the need for antimicrobials for respiratory symptoms and your thoughts on managing symptoms in the future. It should take no more than five minutes to complete the diary each day.
If the trial team have not received your completed daily diary after 14-17 days, they will ask you a brief set of questions, similar to those asked in the diary, by telephone.
You will also be called on or just after day 28, the last day of the follow up period, to ask a brief set of questions about the final two weeks of your illness/recovery. Each telephone call will last no more than five minutes.
TRIAL TEAM
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Joy Rahman
Senior Clinical Trials Manager
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Emma Harper
Trial Manager
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EXTERNAL CO-INVESTIGATORS
Alike van der Velden, University Medical Center Utrecht
Susanne Emmerich, Abbott Rapid Diagnostics Germany GmbH
Adam Zerda, Becton Dickinson
Ben Saville, Berry Consultants
Herman Goossens, University of Antwerp
Evelina Tacconelli, University Verona
Fulvia Mazzaferri, University of Verona
Sibyl Anthierens, University of Antwerp