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Trial record 26 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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

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ClinicalTrials.gov Identifier: NCT03256825
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Helse Møre og Romsdal HF

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Diagnostic Test: Rapid diagnostics alone Other: Real-time antimicrobial stewardship decision support Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Rapid diagnostics
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
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.

Rapid diagnostics and RADS
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
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.

Other: Real-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
Other Name: RADS




Primary Outcome Measures :
  1. All-cause 30-day mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Adherence to guidelines for empirical therapy [ Time Frame: Recorded at inclusion or within 30 days after admission/inclusion. ]
    Antibiotics given before results of microbiology diagnostics.

  2. Total antibiotic consumption in intervention groups and control group compared [ Time Frame: 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

  3. Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group. [ Time Frame: Recorded 30 days after admission/inclusion. ]
  4. Time from admission to optimal antibiotic therapy [ Time Frame: Recorded 30 days after admission/inclusion. ]
    Optimal treatment is defined as the working treatment with the most narrow spectrum possible

  5. Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment [ Time Frame: Recorded within 30 days after admission/inclusion. ]
  6. Treatment duration - intravenous/per oral [ Time Frame: Recorded within 30 days after admission/inclusion. ]
  7. Intensive care unit length of stay [ Time Frame: Recorded within 30 days after admission/inclusion. ]
  8. Hospital length of stay [ Time Frame: Recorded within 30 days after admission/inclusion. ]
  9. Frequency of adherence to treatment suggestions given as RADS [ Time Frame: Recorded within 30 days after admission/inclusion. ]
  10. Frequency of readmission for urinary tract infection within 30 days of discharge [ Time Frame: Recorded within 30 days after admission/inclusion. ]
  11. Turnaround time of rapid diagnostic procedures compared to conventional diagnostics [ Time Frame: Recorded within 30 days after admission/inclusion. ]
  12. Accuracy of rapid diagnostic procedures compared to conventional diagnostics [ Time Frame: Recorded within 30 days after admission/inclusion. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256825


Contacts
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Contact: Einar Nilsen, MD 0047 71122136 einar.nilsen@helse-mr.no
Contact: Kasper Kavli Øvsthus, MD 004771122115 kasper.kavli.ovsthus@helse-mr.no

Locations
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Norway
Molde Hospital Recruiting
Molde, Norway
Contact: Pernille Robinson, MD         
Ålesund Hospital Recruiting
Ålesund, Norway
Contact: Pascal Brüger-Synnes, MD         
Sponsors and Collaborators
Helse Møre og Romsdal HF
Investigators
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Principal Investigator: Einar Nilsen, MD Møre and Romsdal Health Trust

Publications:
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Responsible Party: Helse Møre og Romsdal HF
ClinicalTrials.gov Identifier: NCT03256825     History of Changes
Other Study ID Numbers: RUDE/01-2016
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helse Møre og Romsdal HF:
Diagnostic accuracy
Anti-bacterial agents
Decision support systems, clinical
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents