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Point of Care Susceptibility Testing in Primary Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02323087
Enrollment
377
Registered
2014-12-23
Start date
2015-03-31
Completion date
2016-05-31
Last updated
2016-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

Antibiotic resistance, Point of care tests, Primary Health Care

Brief summary

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

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.

Interventions

DEVICEFLEXICULT™ 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.

DEVICEID 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

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The proportion of patients receiving correct treatment12 monthsCorrect treatment defined as: 1. 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 2. If no antibiotic is given, there is no significant growth in the gold standard

Secondary

MeasureTime frameDescription
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 testing14 monthsAccuracy of the two test

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026