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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02368847
Recruitment Status : Unknown
Verified February 2015 by Latour Katrien, KU Leuven.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Information provided by (Responsible Party):
Latour Katrien, KU Leuven

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Device: Diagnostic tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimizing and Validating the Clinical Algorithm for Diagnosing Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward
Study Start Date : March 2015
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Diagnostic tests
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.
Device: Diagnostic tests
C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine C Reactive Protein level in the blood

Device: Diagnostic tests
Uricult dipslide: Easy-to-perform bacterial culture test for dectecting urinary tract infections in point of care settings

Primary Outcome Measures :
  1. Serious infection [ Time Frame: 2 months ]
    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 :
  1. Reliability of the uricult dipslide in a population of institutionalized older patients [ Time Frame: 2 months ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

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 identifier (NCT number): NCT02368847

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Contact: Katrien Latour, MSc 003226425762
Contact: Jan De Lepeleire, PhD 003216376621

Sponsors and Collaborators
KU Leuven
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Study Director: Jan De Lepeleire, PhD KU Leuven

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Responsible Party: Latour Katrien, Research Assistant, KU Leuven Identifier: NCT02368847     History of Changes
Other Study ID Numbers: UTI_UCP
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015

Keywords provided by Latour Katrien, KU Leuven:
Psychiatric Hospitals

Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Urologic Diseases