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

Helse Møre og Romsdal HF

Status: Completed

Conditions: Urinary Tract Infections

Treatments: Other: Real-time antimicrobial stewardship decision support; Diagnostic Test: Rapid diagnostics alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03256825

RUDE/01-2016

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Rapid diagnostics

Other group

Description:

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.

Treatment:

Diagnostic Test: Rapid diagnostics alone

Rapid diagnostics and RADS

Other group

Description:

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.

Treatment:

Other: Real-time antimicrobial stewardship decision support

Diagnostic Test: Rapid diagnostics alone