Point of Care Susceptibility Testing in Primary Care

NACompletedINTERVENTIONAL
Enrollment

377

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Urinary Tract Infections
Interventions
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

Trial Locations (1)

Unknown

21 General practices in Copenhagen area, Copenhagen

All Listed Sponsors
lead

University of Copenhagen

OTHER

NCT02323087 - Point of Care Susceptibility Testing in Primary Care | Biotech Hunter | Biotech Hunter