Skip to main content
OpenTrials
Completed

NCT Number: NCT02323087

Point of Care Susceptibility Testing in Primary Care

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

21 General practices in Copenhagen area

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FLEXICULT™ SSI-Urinary Kit

Device

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

Device

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

Primary outcomes

  1. The proportion of patients receiving correct treatment

    Time frame: 12 months

    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

Secondary outcomes

  1. The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)

    Time frame: 14 months

  2. -The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)

    Time frame: 14 months

  3. Accuracy of point-of-care urine culture and susceptibility testing

    Time frame: 14 months

    Accuracy of the two test

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2014
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.