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Point of Care Susceptibility Testing in Primary Care

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ClinicalTrials.gov Identifier: NCT02323087
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Anne Holm, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Device: FLEXICULT™ SSI-Urinary Kit Device: ID FlexicultTM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Reducing Antibiotic Resistance: Improved Diagnostics and Treatment for Uncomplicated Urinary Tract Infection in General Practice, Denmark
Study Start Date : March 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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Arm Intervention/treatment
Active Comparator: Culture and susceptibility testing
Urine culture and sensitivity testing will be performed using the FLEXICULT™ SSI-Urinary Kit
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.

Active Comparator: Culture
Point of care culture will be performed using ID FlexicultTM
Device: 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




Primary Outcome Measures :
  1. The proportion of patients receiving correct treatment [ Time Frame: 12 months ]

    Correct treatment defined as:

    1. 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
    2. If no antibiotic is given, there is no significant growth in the gold standard


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323087


Locations
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Denmark
21 General practices in Copenhagen area
Copenhagen, Denmark
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Anne Holm Section of General Practice, Dept. of Public Health, University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne Holm, MD PhD-student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02323087     History of Changes
Other Study ID Numbers: UCCAREWP4FLEX
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016

Keywords provided by Anne Holm, University of Copenhagen:
Antibiotic resistance
Point of care tests
Primary Health Care

Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases