Point of Care Susceptibility Testing in Primary Care

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Device: FLEXICULT™ SSI-Urinary Kit; Device: ID FlexicultTM

• Registration Number: NCT02323087
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-23
• Study Start: 2015-03
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 377

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culture and susceptibility testing	FLEXICULT™ SSI-Urinary Kit	Urine culture and sensitivity testing will be performed using the FLEXICULT™ SSI-Urinary Kit
Culture	ID FlexicultTM	Point of care culture will be performed using ID FlexicultTM

Primary Outcome Measures

Name	Time	Method
The proportion of patients receiving correct treatment	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

Secondary Outcome Measures

Name	Time	Method
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 testing	14 months	Accuracy of the two test

Trial Locations

Locations (1)

21 General practices in Copenhagen area; 🇩🇰 Copenhagen, Denmark