Point of Care Susceptibility Testing in Primary Care

NCT02323087 | Completed

• 1 other identifier: UCCAREWP4FLEX
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

Antibiotic resistance; Point of care tests; Primary Health Care

Outcome Measures

Primary Outcomes (1)

• The proportion of patients receiving correct treatment

  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

  12 months

Secondary Outcomes (3)

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

  14 months

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

  14 months

• Accuracy of point-of-care urine culture and susceptibility testing

  14 months

Study Arms (2)

Culture and susceptibility testing

ACTIVE COMPARATOR

Urine culture and sensitivity testing will be performed using the FLEXICULT™ SSI-Urinary Kit

Device: FLEXICULT™ SSI-Urinary Kit

Culture

ACTIVE COMPARATOR

Point of care culture will be performed using ID FlexicultTM

Device: ID FlexicultTM

Interventions

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.

Culture and susceptibility testing

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

Culture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female adult patients
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

21 General practices in Copenhagen area

Copenhagen, Denmark

Location

Related Publications (3)

• 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.

  PMID: 29042390 DERIVED

• 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.

  PMID: 28569603 DERIVED

• 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.

  PMID: 26292908 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Anne Holm

  Section of General Practice, Dept. of Public Health, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD-student

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 23, 2014
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

DK (1)