Point of Care Susceptibility Testing in Primary Care

University of Copenhagen

Status: Completed

Conditions: Urinary Tract Infections

Treatments: Device: ID FlexicultTM; Device: FLEXICULT™ SSI-Urinary Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT02323087

UCCAREWP4FLEX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 377 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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377 participants in 2 patient groups

Culture and susceptibility testing

Active Comparator group

Description:

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

Treatment:

Device: FLEXICULT™ SSI-Urinary Kit

Culture

Active Comparator group

Description:

Point of care culture will be performed using ID FlexicultTM

Treatment:

Device: ID FlexicultTM