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