Point of Care Susceptibility Testing in Primary Care
May 2, 2016 updated by: Anne Holm, University of Copenhagen
Reducing Antibiotic Resistance: Improved Diagnostics and Treatment for Uncomplicated Urinary Tract Infection in General Practice, Denmark
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
377
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark
- 21 General practices in Copenhagen area
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Culture and susceptibility testing
Urine culture and sensitivity testing will be performed using the FLEXICULT™ SSI-Urinary Kit
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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.
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Active Comparator: Culture
Point of care culture will be performed using ID FlexicultTM
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The proportion of patients receiving correct treatment
Time Frame: 12 months
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Correct treatment defined as:
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)
Time Frame: 14 months
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14 months
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-The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)
Time Frame: 14 months
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14 months
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Accuracy of point-of-care urine culture and susceptibility testing
Time Frame: 14 months
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Accuracy of the two test
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14 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne Holm, Section of General Practice, Dept. of Public Health, University of Copenhagen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Holm A, Cordoba G, Moller Sorensen T, Rem Jessen L, Frimodt-Moller N, Siersma V, Bjerrum L. Effect of point-of-care susceptibility testing in general practice on appropriate prescription of antibiotics for patients with uncomplicated urinary tract infection: a diagnostic randomised controlled trial. BMJ Open. 2017 Oct 16;7(10):e018028. doi: 10.1136/bmjopen-2017-018028.
- Holm A, Cordoba G, Sorensen TM, Jessen LR, Frimodt-Moller N, Siersma V, Bjerrum L. Clinical accuracy of point-of-care urine culture in general practice. Scand J Prim Health Care. 2017 Jun;35(2):170-177. doi: 10.1080/02813432.2017.1333304. Epub 2017 Jun 1.
- Holm A, Cordoba G, Sorensen TM, Jessen LR, Siersma V, Bjerrum L. 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. BMC Fam Pract. 2015 Aug 21;16:106. doi: 10.1186/s12875-015-0322-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
December 11, 2014
First Submitted That Met QC Criteria
December 17, 2014
First Posted (Estimate)
December 23, 2014
Study Record Updates
Last Update Posted (Estimate)
May 3, 2016
Last Update Submitted That Met QC Criteria
May 2, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCCAREWP4FLEX
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