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Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward (UTI_UCP)

Primary Purpose

Urinary Tract Infections

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diagnostic tests
Diagnostic tests
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Tract Infections focused on measuring Aged, Psychiatric Hospitals

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Older (65+ years) persons admitted to a gerontopsychiatric ward

Exclusion Criteria:

  • Patients not understanding Dutch or not willing to participate (no informed consent)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Diagnostic tests

    Arm Description

    For any patient with a suspected urinary tract infection during the course of the study a basic questionnaire will have to be filled out and diagnostic tests (urine sample for culture, dipstick assay for the detection of nitrites and leukocyte- esterase and a POC CRP test) will have to be perform.

    Outcomes

    Primary Outcome Measures

    Serious infection
    To verify if the elderly has a serious infection, the research team will combine test results (dipstick, dipslide and CRP measurement) with signs/symptoms reported in the patient questionnaire.

    Secondary Outcome Measures

    Reliability of the uricult dipslide in a population of institutionalized older patients
    To verify the reliability of the uricult dipslide, a comparison will be made between the result of a dipslide read after 48h at room temperature, a dipslide incubated for 24h at +/- 35° Celsius and a urine culture test performed in a microbiology lab

    Full Information

    First Posted
    February 9, 2015
    Last Updated
    February 17, 2015
    Sponsor
    KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02368847
    Brief Title
    Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward
    Acronym
    UTI_UCP
    Official Title
    Optimizing and Validating the Clinical Algorithm for Diagnosing Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    August 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    KU Leuven

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Urinary tract infections are one of the most common types of infections in older persons. The general aim of this study is to improve the epidemiological knowledge and develop a better diagnostic algorithm for urinary tract infections in older institutionalized individuals in order to reduce excessive prescribing of antibiotics and prevent antimicrobial resistance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infections
    Keywords
    Aged, Psychiatric Hospitals

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic tests
    Arm Type
    Other
    Arm Description
    For any patient with a suspected urinary tract infection during the course of the study a basic questionnaire will have to be filled out and diagnostic tests (urine sample for culture, dipstick assay for the detection of nitrites and leukocyte- esterase and a POC CRP test) will have to be perform.
    Intervention Type
    Device
    Intervention Name(s)
    Diagnostic tests
    Intervention Description
    C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine C Reactive Protein level in the blood
    Intervention Type
    Device
    Intervention Name(s)
    Diagnostic tests
    Intervention Description
    Uricult dipslide: Easy-to-perform bacterial culture test for dectecting urinary tract infections in point of care settings
    Primary Outcome Measure Information:
    Title
    Serious infection
    Description
    To verify if the elderly has a serious infection, the research team will combine test results (dipstick, dipslide and CRP measurement) with signs/symptoms reported in the patient questionnaire.
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Reliability of the uricult dipslide in a population of institutionalized older patients
    Description
    To verify the reliability of the uricult dipslide, a comparison will be made between the result of a dipslide read after 48h at room temperature, a dipslide incubated for 24h at +/- 35° Celsius and a urine culture test performed in a microbiology lab
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Older (65+ years) persons admitted to a gerontopsychiatric ward Exclusion Criteria: Patients not understanding Dutch or not willing to participate (no informed consent)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katrien Latour, MSc
    Phone
    003226425762
    Email
    katrien.latour@kuleuven.be
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jan De Lepeleire, PhD
    Phone
    003216376621
    Email
    jan.delepeleire@med.kuleuven.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan De Lepeleire, PhD
    Organizational Affiliation
    KU Leuven
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward

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