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Point of Care Susceptibility Testing in Primary Care

Information source: University of Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Tract Infections

Intervention: FLEXICULTâ„¢ SSI-Urinary Kit (Device); ID FlexicultTM (Device)

Phase: N/A

Status: Recruiting

Sponsored by: University of Copenhagen

Official(s) and/or principal investigator(s):
Anne Holm, Principal Investigator, Affiliation: Section of General Practice, Dept. of Public Health, University of Copenhagen

Overall contact:
Anne Holm, Cand.Med., Phone: +45 35 33 72 44, Email: anneholm@sund.ku.dk


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: The proportion of patients receiving correct treatment

Secondary outcome:

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)

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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)

Locations and Contacts

Anne Holm, Cand.Med., Phone: +45 35 33 72 44, Email: anneholm@sund.ku.dk

21 General practices in Copenhagen area, Copenhagen, Denmark; Recruiting
Anne Holm, MD, Phone: +4561678181, Email: anneholm@sund.ku.dk
Additional Information

Starting date: March 2015
Last updated: May 26, 2015

Page last updated: August 23, 2015

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