Urinary Tract InfectionsRUDENCT03256825
Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support
A study testing Rapid diagnostics alone and Real-time antimicrobial stewardship decision support in people with Urinary Tract Infections, run by Helse Møre og Romsdal HF at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Rapid diagnostics alone and Real-time antimicrobial stewardship decision support
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Sep 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Other simultaneous infections that warrant systemic antimicrobial therapy or surgery.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption
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.
Read the 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:
- 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
- Conditions
- Urinary Tract Infections
- Being tested
- Rapid diagnostics alone, Real-time antimicrobial stewardship decision support
- Keywords
- Diagnostic accuracy, Anti-bacterial agents, Decision support systems, clinical
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid diagnostics aloneDiagnostic test
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.
Real-time antimicrobial stewardship decision supportOther
Also called RADS
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
| Study group | Role | What they receive |
|---|---|---|
| Rapid diagnostics | Other | 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. Receives: Diagnostic Test: Rapid diagnostics alone |
| Rapid diagnostics and RADS | Other | 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. Receives: Diagnostic Test: Rapid diagnostics alone; Other: Real-time antimicrobial stewardship decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause 30-day mortality
Measured: 30 days
Secondary outcomes (12)
Adherence to guidelines for empirical therapy
Antibiotics given before results of microbiology diagnostics.
Measured: 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
Measured: Recorded at inclusion or within 30 days after admission/inclusion.
Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group.
Measured: 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
Measured: Recorded 30 days after admission/inclusion.
Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment
Measured: Recorded within 30 days after admission/inclusion.
Treatment duration - intravenous/per oral
Measured: Recorded within 30 days after admission/inclusion.
Intensive care unit length of stay
Measured: Recorded within 30 days after admission/inclusion.
Hospital length of stay
Measured: Recorded within 30 days after admission/inclusion.
Frequency of adherence to treatment suggestions given as RADS
Measured: Recorded within 30 days after admission/inclusion.
Frequency of readmission for urinary tract infection within 30 days of discharge
Measured: Recorded within 30 days after admission/inclusion.
Turnaround time of rapid diagnostic procedures compared to conventional diagnostics
Measured: Recorded within 30 days after admission/inclusion.
Accuracy of rapid diagnostic procedures compared to conventional diagnostics
Measured: Recorded within 30 days after admission/inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 Sep 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Einar Nilsen, MD, Principal investigator, Møre and Romsdal Health Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256825
- Sponsor's protocol ID
- RUDE/01-2016
- Acronym
- RUDE
- Status last verified
- May 2020
- First submitted
- 15 Aug 2017
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other investigators.
Publications
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.
PubMed 22831285
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption
- ClinicalTrials.gov ID
- NCT03256825
- Acronym / sponsor ID
- RUDE / RUDE/01-2016
- Conditions
- Urinary Tract Infections
- Keywords
- Diagnostic accuracy, Anti-bacterial agents, Decision support systems, clinical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid diagnostics | Other | Diagnostic Test: Rapid diagnostics alonepatients admitted to medical and surgical wards with urinary tract infections at Ålesund Hospital, Moere and Romsdal, Norway. Here, rapid diagnostics alone will be implemented. |
| Rapid diagnostics and RADS | Other | Diagnostic Test: Rapid diagnostics alone, Other: Real-time antimicrobial stewardship decision supportpatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Other simultaneous infections that warrant systemic antimicrobial therapy or surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid diagnostics aloneUrine 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. | Diagnostic test | Rapid diagnostics, Rapid diagnostics and RADS |
| Real-time antimicrobial stewardship decision supportAlso: RADSA 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 | Other | Rapid diagnostics and RADS |
Primary outcome
All-cause 30-day mortality
Time frame: 30 days
12 secondary outcomes
Adherence to guidelines for empirical therapy
Time frame: Recorded at inclusion or within 30 days after admission/inclusion.
Total antibiotic consumption in intervention groups and control group compared
Time frame: Recorded at inclusion or 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.
Time from admission to optimal antibiotic therapy
Time frame: Recorded 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.
Treatment duration - intravenous/per oral
Time frame: Recorded within 30 days after admission/inclusion.
Intensive care unit length of stay
Time frame: Recorded within 30 days after admission/inclusion.
Hospital length of stay
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.
Frequency of readmission for urinary tract infection within 30 days of discharge
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.
Accuracy of rapid diagnostic procedures compared to conventional diagnostics
Time frame: Recorded within 30 days after admission/inclusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 22831285Nilsen 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.
- Individual participant dataSharing planned: No. No IPD will be shared with other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Einar Nilsen, MD principal investigator
Møre and Romsdal Health Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid diagnostics alone and Real-time antimicrobial stewardship decision support in people with Urinary Tract Infections, run by Helse Møre og Romsdal HF at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause 30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03256825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.