Urinary Tract InfectionsNCT02323087
Point of Care Susceptibility Testing in Primary Care
A study testing FLEXICULT™ SSI-Urinary Kit and ID FlexicultTM in people with Urinary Tract Infections, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- FLEXICULT™ SSI-Urinary Kit and ID FlexicultTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- FLEXICULT™ SSI-Urinary Kit, ID FlexicultTM
- Keywords
- Antibiotic resistance, Point of care tests, Primary Health Care
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEXICULT™ SSI-Urinary KitDevice
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.
ID FlexicultTMDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Culture and susceptibility testing | Active comparator | Urine culture and sensitivity testing will be performed using the FLEXICULT™ SSI-Urinary Kit Receives: Device: FLEXICULT™ SSI-Urinary Kit |
| Culture | Active comparator | Point of care culture will be performed using ID FlexicultTM Receives: Device: ID FlexicultTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)
Measured: 14 months
-The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)
Measured: 14 months
Accuracy of point-of-care urine culture and susceptibility testing
Accuracy of the two test
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Holm, University of Copenhagen
- Investigators
- Anne Holm, Principal investigator, Section of General Practice, Dept. of Public Health, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323087
- Sponsor's protocol ID
- UCCAREWP4FLEX
- Status last verified
- May 2016
- First submitted
- 11 Dec 2014
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29042390Holm 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.
PubMed 28569603Holm 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.
PubMed 26292908
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Antibiotic Resistance: Improved Diagnostics and Treatment for Uncomplicated Urinary Tract Infection in General Practice, Denmark
- ClinicalTrials.gov ID
- NCT02323087
- Acronym / sponsor ID
- UCCAREWP4FLEX
- Conditions
- Urinary Tract Infections
- Keywords
- Antibiotic resistance, Point of care tests, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culture and susceptibility testing | Active comparator | Device: FLEXICULT™ SSI-Urinary KitUrine culture and sensitivity testing will be performed using the FLEXICULT™ SSI-Urinary Kit |
| Culture | Active comparator | Device: ID FlexicultTMPoint of care culture will be performed using ID FlexicultTM |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Negative dipstick analysis
- Complicated urinary tract infection
- Known pregnancy
- Severe systemic symptoms, high fever, flank pain
- Recent bladder surgery (within past 4 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLEXICULT™ SSI-Urinary KitUrine 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. | Device | Culture and susceptibility testing |
| ID FlexicultTMPoint 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 | Device | Culture |
Primary outcome
The proportion of patients receiving correct treatment
Time frame: 12 months
Correct 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
3 secondary outcomes
The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)
Time frame: 14 months
-The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)
Time frame: 14 months
Accuracy of point-of-care urine culture and susceptibility testing
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Derived from this study: PubMed 29042390Holm 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.
- Derived from this study: PubMed 28569603Holm 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.
- Derived from this study: PubMed 26292908Holm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Holm principal investigator
Section of General Practice, Dept. of Public Health, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEXICULT™ SSI-Urinary Kit and ID FlexicultTM in people with Urinary Tract Infections, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients receiving correct treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323087, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.