Point of Care Susceptibility Testing in Primary Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-05-31

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.

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Culture and susceptibility testing

Urine culture and sensitivity testing will be performed using the FLEXICULT™ SSI-Urinary Kit

Group Type ACTIVE_COMPARATOR

FLEXICULT™ SSI-Urinary Kit

Intervention Type DEVICE

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.

Culture

Point of care culture will be performed using ID FlexicultTM

Group Type ACTIVE_COMPARATOR

ID FlexicultTM

Intervention Type DEVICE

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

Interventions

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FLEXICULT™ SSI-Urinary Kit

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.

Intervention Type DEVICE

ID FlexicultTM

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

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No