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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05039203
Other study ID # 2021-02410
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 24, 2022
Est. completion date September 2024

Study information

Verified date August 2023
Source Region Stockholm
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigation of 1. The incidence of symptomatic bacteriuria during four weeks after removal of an IUC in inpatients at a rehabilitation clinic for patients ≥ 65 years compared with the incidence of symptomatic bacteriuria among inpatients not treated with an IUC and 2. For how long does ABU persist in inpatients at a rehabilitation clinic for patients ≥ 65 years during a follow-up time of four weeks after IUC-removal?


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 800
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Admission to a rehabilitation clinic for patients = 65 years in Stockholm County, Sweden - Ability to understand oral and written instructions in Swedish - Ability to produce a voided urine-sample Exclusion Criteria: - Severe cognitive failure and/or disability to understand oral and written instructions in Swedish according to the healthcare-personnel's judgment at the ward - End-of-life care - Physical disability to produce voided urine-samples - Ongoing antimicrobial treatment for symptomatic bacteriuria

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Indwelling urinary catheter
Removal of indwelling urinary catheter

Locations

Country Name City State
Sweden Geriatric Department, Södertälje Hospital Södertälje

Sponsors (1)

Lead Sponsor Collaborator
Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symptomatic bacteriuria (urinary tract infection) Clinical diagnosis of urinary tract infection by a physician Four weeks
Secondary Asymptomatic bacteriuria (ABU) Prevalence of ABU at the point of removal of an IUC compared with patients without IUC One day
Secondary Persistence of ABU For how long does ABU persist after IUC-removal Four weeks
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