NCT02368847

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

5 months

First QC Date

February 9, 2015

Last Update Submit

February 17, 2015

Conditions

Keywords

AgedPsychiatric Hospitals

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Secondary Outcomes (1)

  • Reliability of the uricult dipslide in a population of institutionalized older patients

    2 months

Study Arms (1)

Diagnostic tests

OTHER

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

Interventions

C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine C Reactive Protein level in the blood

Diagnostic tests

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jan De Lepeleire, PhD

    KU Leuven

    STUDY DIRECTOR

Central Study Contacts

Katrien Latour, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 23, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2015

Record last verified: 2015-02