Point of Care Susceptibility Testing in Primary Care

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323087
• Other study ID #: UCCAREWP4FLEX
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: May 2, 2016
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Device:
• FLEXICULT™ SSI-Urinary Kit
Urine culture and sensitivity testing will be performed on the intervention group by means of a POCT, the FLEXICULT™ SSI-Urinary Kit. The kit is designed as an ordinary Petri dish but with higher sides. The Petri dish is divided into 6 compartments: 1 large one for quantitative analysis and 5 smaller ones for susceptibility testing (Fig. 1). The agar in each of the smaller compartments contains 1 of 5 antimicrobials: trimethoprim, sulfamethoxazole, ampicillin, nitrofurantoin and mecillinam. The agar plate is flooded with the urine specimen for a couple of seconds and then incubated at 35°C over night. The following day the plate is read. When reading the compartment for quantitative analysis the lower limit is:103 colony-forming units (cfu) per milliliter.
• ID FlexicultTM
Point of care culture will be performed using ID FlexicultTM,which is a chromogenic agar plate for identification and quantitation of urinary tract pathogens. The agar plate is for cultivation of urine, which makes it possible to identify the bacteria and quantitate the amount of bacteria. Based on bacterial colony color and size can be determined which bacteria are involved. For example, an E. coli bacteria will grow with big red colonies, and Enterobacter sp. will grow with large dark blue / purple colonies. The sample is seeded with a 10 uL inoculation needle, the lid is applied and the agar plate incubated with the lid down at 35 0C overnight. The plate is read the next day

Locations

Country	Name	City	State
Denmark	21 General practices in Copenhagen area	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients receiving correct treatment	Correct treatment defined as: 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; If no antibiotic is given, there is no significant growth in the gold standard	12 months	No
Secondary	The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)		14 months	No
Secondary	-The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)		14 months	No
Secondary	Accuracy of point-of-care urine culture and susceptibility testing	Accuracy of the two test	14 months	No