Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support

Study Overview
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Brief Summary
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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
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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: Switch to active treatment if non-working empirical treatment De-escalate broad spectrum empiric treatment when feasible Promote early intravenous to per oral switch Shorten treatment duration

Official Title
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Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Diagnostic Test: Rapid diagnostics alone
* Other: Real-time antimicrobial stewardship decision support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rapid diagnostics<br>patients admitted to medical and surgical wards with urinary tract infections at Ålesund Hospital, Moere and Romsdal, Norway. Here, rapid diagnostics alone will be implemented. | Diagnostic Test: Rapid diagnostics alone<br>* 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.<br>|
| Other: Rapid diagnostics and RADS<br>patients admitted to medical and surgical wards with urinary tract infections at Molde Hospital, Moere and Romsdal, Norway. Here, rapid diagnostics will be implemented in conjunction with Real-time antimicrobial stewardship decision support : rapid diagnostics and RADS. | Diagnostic Test: Rapid diagnostics alone<br>* 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.<br>Other: Real-time antimicrobial stewardship decision support<br>* A clinical microbiologist will be give RADS by phone to a designated clinician with the aim of: Switch to active treatment if non-working empirical treatment De-escalate broad spectrum empiric treatment when feasible Promote early intravenous to per oral switch Shorten treatment duration<br>* Other names: RADS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause 30-day mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to guidelines for empirical therapy | Antibiotics given before results of microbiology diagnostics. | Recorded at inclusion or within 30 days after admission/inclusion. | 
| Total antibiotic consumption in intervention groups and control group compared | 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 | Recorded at inclusion or within 30 days after admission/inclusion. | 
| 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 | Optimal treatment is defined as the working treatment with the most narrow spectrum possible | Recorded 30 days after admission/inclusion. | 
| 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. | 
| Intensive care unit length of stay |  | Recorded within 30 days after admission/inclusion. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic accuracy, Anti-bacterial agents, Decision support systems, clinical