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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03256825
• Date of registration: 15/08/2017
• Prospective Registration: Yes
• Primary sponsor: Helse Møre og Romsdal HF
• Public title: Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support RUDE
• Scientific title: Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption
• Date of first enrolment: September 1, 2017
• Target sample size: 400
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03256825
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Einar Nilsen, MD
• Affiliation: Møre and Romsdal Health Trust

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Urinary Tract Infections

Intervention(s)

Diagnostic Test: Rapid diagnostics alone

Other: Real-time antimicrobial stewardship decision support

Primary Outcome(s)

All-cause 30-day mortality [Time Frame: 30 days]

Secondary Outcome(s)

Total antibiotic consumption in intervention groups and control group compared [Time Frame: Recorded at inclusion or within 30 days after admission/inclusion.]

Frequency of readmission for urinary tract infection within 30 days of discharge [Time Frame: Recorded within 30 days after admission/inclusion.]

Hospital length of stay [Time Frame: Recorded within 30 days after admission/inclusion.]

Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment [Time Frame: Recorded within 30 days after admission/inclusion.]

Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group. [Time Frame: Recorded 30 days after admission/inclusion.]

Adherence to guidelines for empirical therapy [Time Frame: Recorded at inclusion or within 30 days after admission/inclusion.]

Intensive care unit length of stay [Time Frame: Recorded within 30 days after admission/inclusion.]

Turnaround time of rapid diagnostic procedures compared to conventional diagnostics [Time Frame: Recorded within 30 days after admission/inclusion.]

Time from admission to optimal antibiotic therapy [Time Frame: Recorded 30 days after admission/inclusion.]

Treatment duration - intravenous/per oral [Time Frame: Recorded within 30 days after admission/inclusion.]

Accuracy of rapid diagnostic procedures compared to conventional diagnostics [Time Frame: Recorded within 30 days after admission/inclusion.]

Frequency of adherence to treatment suggestions given as RADS [Time Frame: Recorded within 30 days after admission/inclusion.]

Secondary ID(s)

RUDE/01-2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors