Point of care susceptibility testing in primary care - does it lead to a more appropriate prescription of antibiotics in patients with uncomplicated urinary tract infections? Protocol for a randomized controlled trial.

Anne Holm,Gloria Cordoba,Lisbeth Rem Jessen,Tina Møller Sørensen,Volkert Siersma,Lars Bjerrum

doi:10.1186/s12875-015-0322-x

Abstract

BackgroundUrinary tract infection (UTI) is a common infection in primary care and is the second leading reason for prescription of antibiotics in Denmark. The diagnosis is often based on symptoms and urine dip-stick, which has limited validity, causing the risk of unnecessary antibiotic prescription. Additionally, with increasing antibiotic resistance, the risk of choosing an antibiotic to which an infecting pathogen is resistant is rising. Combined point-of-care-tests (POCT) for urine culture and susceptibility testing have been developed and validated for primary care, and performing such a test in all patients with suspected UTI in primary care seems rational in order to reduce the use of inappropriate antibiotics. However, the clinical effect of the culture and susceptibility test has not yet been investigated. This study aims to investigate whether POCT urine culture and susceptibility testing decreases the inappropriate use of antibiotics and leads to faster patient recovery.Methods/designRandomized controlled open label trial of two diagnostic approaches. 750 patients with symptoms of uncomplicated UTI, consecutively contacting their general practitioner (GP), randomized to either POCT urine culture and susceptibility testing and targeted treatment or POCT urine culture without susceptibility testing and empirical treatment. Treatment is started when the POCT is read. The two groups are compared with regard to appropriate choice of antibiotics, clinical remission, and microbiological cure rates.DiscussionThe results of this study may provide important evidence to recommend POCT culture and susceptibility testing in all patients with suspected uncomplicated UTI. This could become an additional strategy to fight antibiotic resistance.Trial registrationClinicalTrials.gov NCT02323087.

Highlights

Urinary tract infection (UTI) is a common infection in primary care and is the second leading reason for prescription of antibiotics in Denmark
This study aims to answer the questions: 1) Does POCT urine culture and susceptibility testing decrease the use of inappropriate antibiotics, and 2) Does targeted therapy improve clinical outcomes in patients with suspected uncomplicated UTI in general practice when compared to POCT urine culture without susceptibility testing? We hypothesize that the use of POCT susceptibility testing improves the following outcomes: Appropriate choice of antibiotic, clinical remission, and microbiological cure rate
In Denmark, POCT combined culture and susceptibility testing has been in use for decades, and the use has increased since introduction of the FLEXICULTTM SSIUrinary Kit

Summary

Introduction

Urinary tract infection (UTI) is a common infection in primary care and is the second leading reason for prescription of antibiotics in Denmark. Combined point-of-care-tests (POCT) for urine culture and susceptibility testing have been developed and validated for primary care, and performing such a test in all patients with suspected UTI in primary care seems rational in order to reduce the use of inappropriate antibiotics. This study aims to investigate whether POCT urine culture and susceptibility testing decreases the inappropriate use of antibiotics and leads to faster patient recovery. Primary health care in Denmark is responsible for about 90 % of all redeemed prescriptions of antibiotics, and it is known that a high out-patient consumption of antibiotics leads to high levels of resistance [2, 3]. In Denmark, Holm et al BMC Family Practice (2015) 16:106

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