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Tackling the neglected disease in our midst: Towards evidence-based treatment decisions for urinary tract infections at point-of-care.

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Emma Hayhurst and Jeroen Nieuwland (Llusern Scientific)

Alison King (CTMUHB Pathology)

PUBLIC / CYHOEDDUS

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Project Background

  • UTIs are:
    • The second most common bacterial infection globally
    • Primarily a disease of women and the elderly
    • A significant burden on primary and secondary care
    • Increasing with an ageing population
    • Key in the fight against AMR
    • Capable of causing long term severe complications
    • Not easy to diagnose – no good tools available at point-of-care

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  • This project is a collaboration between academic, industry and healthcare partners

PUBLIC / CYHOEDDUS

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UTI Case Studies: Unmet health needs

“You need to improve your personal

hygiene”

“That’s just what women need to put

up with”

“The test is negative, you can’t have

a UTI”

Years of debilitating pain

Feeling hopeless and ashamed

Severe infections/hospitalisation/sepsis

PUBLIC / CYHOEDDUS

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Aims and Objectives

Overall Aim: To improve diagnosis and treatment of UTIs

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Objective One: To validate the performance of our novel UTI test for use at POC

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Objective Two: To evaluate the test’s potential clinical impact

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Objective Three: To determine a pathway for the wider adoption and implementation of the test

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PUBLIC / CYHOEDDUS

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Project Approach

Objective One: Clinical performance evaluation

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Objective Two: User focus groups and product demonstrations (Tritech)

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Objective Three: Engage with commercial partners and determine our route to market

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vs

PUBLIC / CYHOEDDUS

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Project Outcomes and Results

1. Clinical Performance Evaluation

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  • Good clinical sensitivity and specificity

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  • Our test is better at detecting true infections in ‘mixed growth’ samples

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  • Our test may work as a ‘rule out’ test to improve antibiotic stewardship at point-of-care

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  • Our test could have impact in primary, secondary, emergency and community care settings

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Sensitivity

Specificity

E. coli

(n=168)

85%

89%

Klebsiella spp.

(n=67)

82%

91%

Enterococcus spp.

(n=55)

93%

89%

Proteus mirabilis*

(n=53)

79%

100%

Staphylococcus saprophyticus

(n=58)

92%

100%

Pseudomonas aeruginosa*

(n=30)

100%

96%

PUBLIC / CYHOEDDUS

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Project Outcomes and Results

2. Potential clinical impact

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Opportunities:

  • Confidence in a negative - a ‘rule out’ test to improve antibiotic stewardship at point-of-care
  • Useful in remote and out-of-hours settings
  • May reduce issues with contaminated samples

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Challenges:

  • Behavioural change from symptom-based prescribing needed
  • Cost implications
  • 40 minutes might be too long

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PUBLIC / CYHOEDDUS

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Project Outcomes and Results

3. Pathway to adopt and spread

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  • UK CA marking
  • Real-world evaluations
  • Comparison with dipsticks
  • Engagement with policy makers

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PUBLIC / CYHOEDDUS

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What Next?

  • Investment of £750,000 secured to bring UTI test to market

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  • Commercial pathway clearly mapped out

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  • Setting up our production labs in Cardiff Edge Business Park

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  • Independent NIHR-funded performance evaluation of test in primary care and care homes

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  • Explore use and impact of test in different clinical settings

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PUBLIC / CYHOEDDUS

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Conclusions

  • Potential impact of improving UTI diagnosis and treatment is huge with patient benefits, cost savings and improved antibiotic stewardship

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  • Thank you to the Bevan Commission for funding and making this project possible. It has provided crucial clinical data and user feedback for us to make our UTI test a reality

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PUBLIC / CYHOEDDUS

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Outputs and Accolades

BSAC UTI conference

(now published in JAC AMR)

PUBLIC / CYHOEDDUS