Urinary Tract Infections
Conditions
Keywords
Diagnostic accuracy, Anti-bacterial agents, Decision support systems, clinical
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
Interventions
DIAGNOSTIC_TESTRapid diagnostics alone
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.
OTHERReal-time antimicrobial stewardship decision support
A clinical microbiologist will be give RADS by phone 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
Sponsors
Helse Møre og Romsdal HF
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause 30-day mortality | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total antibiotic consumption in intervention groups and control group compared | Recorded at inclusion or within 30 days after admission/inclusion. | Total consumption of antibiotic during admission and prescribed oral antibiotics after discharge. Expressed in (DDD) the assumed average maintenance dose per day for the drug used for its main indication in adults / admission |
| Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group. | Recorded 30 days after admission/inclusion. | — |
| Time from admission to optimal antibiotic therapy | Recorded 30 days after admission/inclusion. | Optimal treatment is defined as the working treatment with the most narrow spectrum possible |
| Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment | Recorded within 30 days after admission/inclusion. | — |
| Treatment duration - intravenous/per oral | Recorded within 30 days after admission/inclusion. | — |
| Adherence to guidelines for empirical therapy | Recorded at inclusion or within 30 days after admission/inclusion. | Antibiotics given before results of microbiology diagnostics. |
| Hospital length of stay | Recorded within 30 days after admission/inclusion. | — |
| Frequency of adherence to treatment suggestions given as RADS | Recorded within 30 days after admission/inclusion. | — |
| Frequency of readmission for urinary tract infection within 30 days of discharge | Recorded within 30 days after admission/inclusion. | — |
| Turnaround time of rapid diagnostic procedures compared to conventional diagnostics | Recorded within 30 days after admission/inclusion. | — |
| Accuracy of rapid diagnostic procedures compared to conventional diagnostics | Recorded within 30 days after admission/inclusion. | — |
| Intensive care unit length of stay | Recorded within 30 days after admission/inclusion. | — |
Countries
Norway
Outcome results
None listed