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