Point of Care Susceptibility Testing in Primary Care

Study Overview
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Brief Summary
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The purpose of this study is to determine whether point-of-care susceptibility testing improve correct choice of antibiotics, clinical and microbiological outcome in patients with uncomplicated urinary tract infection in general practice compared to point-of-care urine culture.

Detailed Description
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700-900 patients with symptoms of uncomplicated urinary tract infection, consecutively contacting their GP, randomized to either point of care test (POCT) urine culture and empirical treatment or POCT urine culture and susceptibility testing and targeted treatment. Patients are included until 440 with verified positive cultures are included. The two groups are compared with regard to correct choice of antibiotics, clinical remission and microbiological cure rates.

Official Title
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Reducing Antibiotic Resistance: Improved Diagnostics and Treatment for Uncomplicated Urinary Tract Infection in General Practice, Denmark

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Device: FLEXICULT™ SSI-Urinary Kit
* Device: ID FlexicultTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female adult patients 18 years or older Presenting at their GP with dysuria Frequency or urgency, which have been present for 7 days or less and where the GP suspects uncomplicated UTI. Patients should be able to deliver a mid-stream urine sample, to provide informed consent and be willing and able to fill out a symptom diary. Exclusion Criteria: Negative dipstick analysis Complicated urinary tract infection Known pregnancy Severe systemic symptoms, high fever, flank pain Recent bladder surgery (within past 4 weeks) Urinary tract abnormalities Serious systemic disease Life-threatening cancer Insulin dependent diabetes Long-term corticosteroid treatment Other conditions with compromised immunity Former participation in the study Patients presenting on a Friday (since the POCT must be read after 24 hours)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Culture and susceptibility testing<br>Urine culture and sensitivity testing will be performed using the FLEXICULT™ SSI-Urinary Kit | Device: FLEXICULT™ SSI-Urinary Kit<br>* Urine culture and sensitivity testing will be performed on the intervention group by means of a POCT, the FLEXICULT™ SSI-Urinary Kit. The kit is designed as an ordinary Petri dish but with higher sides. The Petri dish is divided into 6 compartments: 1 large one for quantitative analysis and 5 smaller ones for susceptibility testing (Fig. 1). The agar in each of the smaller compartments contains 1 of 5 antimicrobials: trimethoprim, sulfamethoxazole, ampicillin, nitrofurantoin and mecillinam. The agar plate is flooded with the urine specimen for a couple of seconds and then incubated at 35°C over night. The following day the plate is read. When reading the compartment for quantitative analysis the lower limit is:103 colony-forming units (cfu) per milliliter.<br>|
| Active Comparator: Culture<br>Point of care culture will be performed using ID FlexicultTM | Device: ID FlexicultTM<br>* Point of care culture will be performed using ID FlexicultTM,which is a chromogenic agar plate for identification and quantitation of urinary tract pathogens. The agar plate is for cultivation of urine, which makes it possible to identify the bacteria and quantitate the amount of bacteria. Based on bacterial colony color and size can be determined which bacteria are involved. For example, an E. coli bacteria will grow with big red colonies, and Enterobacter sp. will grow with large dark blue / purple colonies. The sample is seeded with a 10 uL inoculation needle, the lid is applied and the agar plate incubated with the lid down at 35 0C overnight. The plate is read the next day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients receiving correct treatment | Correct treatment defined as: If an antibiotic is given, there is significant growth of one or more organisms in the gold standard, which all are sensitive to the given antibiotic. The antibiotic must be one of the recommended first-choice treatments unless the organism(s) is/are resistant to or the patient is allergic If no antibiotic is given, there is no significant growth in the gold standard | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure) |  | 14 months | 
| -The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure) |  | 14 months | 
| Accuracy of point-of-care urine culture and susceptibility testing | Accuracy of the two test | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic resistance, Point of care tests, Primary Health Care