Clinical trial NCT02323087: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: Antibiotic resistance
Point of care tests
Primary Health Care
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 377
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: The proportion of patients receiving correct treatment
timeFrame: 12 months
Secondary outcomes:
measure: The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)
timeFrame: 14 months
measure: -The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)
timeFrame: 14 months
measure: Accuracy of point-of-care urine culture and susceptibility testing
timeFrame: 14 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: 21 General practices in Copenhagen area
Study officials:
affiliation: Section of General Practice, Dept. of Public Health, University of Copenhagen
name: Anne Holm
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.