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Point of Care Susceptibility Testing in Primary Care

Primary Purpose

Urinary Tract Infections

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

FLEXICULT™ SSI-Urinary Kit

ID FlexicultTM

About this trial

This is an interventional diagnostic trial for Urinary Tract Infections focused on measuring Antibiotic resistance, Point of care tests, Primary Health Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

21 General practices in Copenhagen area

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Culture and susceptibility testing

Culture

Arm Description

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

Point of care culture will be performed using ID FlexicultTM

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)

-The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)

Accuracy of point-of-care urine culture and susceptibility testing

Accuracy of the two test

Full Information

NCT ID

NCT02323087

First Posted

December 11, 2014

Last Updated

May 2, 2016

Sponsor

University of Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT02323087

Brief Title

Point of Care Susceptibility Testing in Primary Care

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Copenhagen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

Keywords

Antibiotic resistance, Point of care tests, Primary Health Care

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

377 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Culture and susceptibility testing

Arm Type

Active Comparator

Arm Description

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

Arm Title

Culture

Arm Type

Active Comparator

Arm Description

Point of care culture will be performed using ID FlexicultTM

Intervention Type

Device

Intervention Name(s)

FLEXICULT™ SSI-Urinary Kit

Intervention Description

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

Intervention Name(s)

ID FlexicultTM

Intervention Description

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

Primary Outcome Measure Information:

Title

The proportion of patients receiving correct treatment

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)

Time Frame

14 months

Title

-The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)

Time Frame

14 months

Title

Accuracy of point-of-care urine culture and susceptibility testing

Description

Accuracy of the two test

Time Frame

14 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Holm

Organizational Affiliation

Section of General Practice, Dept. of Public Health, University of Copenhagen

Official's Role

Principal Investigator

Facility Information:

Facility Name

21 General practices in Copenhagen area

City

Copenhagen

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

29042390

Citation

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.

Results Reference

derived

PubMed Identifier

28569603

Citation

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.

Results Reference

derived

PubMed Identifier

26292908

Citation

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.

Results Reference

derived

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Point of Care Susceptibility Testing in Primary Care

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