Clinical trial NCT03256825: Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support
Official title: Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: Diagnostic accuracy
Anti-bacterial agents
Decision support systems, clinical
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
First posted: 2017-08-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to assess the accuracy and impact of rapid diagnosis and rapid diagnosis decision support on different aspects of antibiotic consumption when implemented alone or together.

Detailed description: This interventional study in two centers compares two groups with each other and with a pre-intervention control group. In group 1 rapid techniques for handling urine cultures will be the only intervention. In group 2 rapid diagnostics will be supplemented with real-time antimicrobial stewardship decision support (RADS). In each center two departments will be involved.

Urine samples present at the laboratory at opening on weekdays will be screened using urine flow cytometry and microscopy of centrifuged gram stained urine. Samples found positive for significant mono microbial bacteriuria will be investigated further by using direct automated phenotypic identification and antimicrobial susceptibility determination and screened for inclusion in the interventional study.

In one of the centers, rapid techniques will be coupled to real-time antimicrobial stewardship decision support (RADS). RADS will be given by telephone to a designated clinician with the aim of:

1. Switch to active treatment if non-working empirical treatment
2. De-escalate broad spectrum empiric treatment when feasible
3. Promote early intravenous to per oral switch
4. Shorten treatment duration

Eligibility criteria: Inclusion Criteria:

* Urine sample present at the laboratory weekdays
* At least 11 ml of urine in sample
* Admitted to surgical or medical ward.
* Urine sample taken on admission to hospital.
* Rapid diagnostics suggesting mono microbial growth of \> 100.000 microbes/ml urine.
* Clinical and laboratory signs/symptoms of urinary tract infection at time of sample delivery.

Exclusion Criteria:

* Other simultaneous infections that warrant systemic antimicrobial therapy or surgery.

Primary outcomes:
measure: All-cause 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: Adherence to guidelines for empirical therapy
timeFrame: Recorded at inclusion or within 30 days after admission/inclusion.
measure: Total antibiotic consumption in intervention groups and control group compared
timeFrame: Recorded at inclusion or within 30 days after admission/inclusion.
measure: Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group.
timeFrame: Recorded 30 days after admission/inclusion.
measure: Time from admission to optimal antibiotic therapy
timeFrame: Recorded 30 days after admission/inclusion.
measure: Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment
timeFrame: Recorded within 30 days after admission/inclusion.
measure: Treatment duration - intravenous/per oral
timeFrame: Recorded within 30 days after admission/inclusion.
measure: Intensive care unit length of stay
timeFrame: Recorded within 30 days after admission/inclusion.
measure: Hospital length of stay
timeFrame: Recorded within 30 days after admission/inclusion.
measure: Frequency of adherence to treatment suggestions given as RADS
timeFrame: Recorded within 30 days after admission/inclusion.
measure: Frequency of readmission for urinary tract infection within 30 days of discharge
timeFrame: Recorded within 30 days after admission/inclusion.
measure: Turnaround time of rapid diagnostic procedures compared to conventional diagnostics
timeFrame: Recorded within 30 days after admission/inclusion.
measure: Accuracy of rapid diagnostic procedures compared to conventional diagnostics
timeFrame: Recorded within 30 days after admission/inclusion.
Other outcomes:
Locations:
city: Molde
country: Norway
facility: Molde Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
affiliation: Møre and Romsdal Health Trust
name: Einar Nilsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsen E. Automated identification and susceptibility determination directly from blood cultures facilitates early targeted antibiotic therapy. Scand J Infect Dis. 2012 Nov;44(11):860-5. doi: 10.3109/00365548.2012.689848. Epub 2012 Jul 25.