NCT02323087

Point of Care Susceptibility Testing in Primary Care

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-12-23
• Last updated: 2016-05-03

Locations

1 site across 1 country: Denmark