Bacteriuria AsymptomaticNCT05039203
Bacteriuria and Indwelling Urinary Catheter.
An observational study of Bacteriuria Asymptomatic and Urinary Tract Infections, run by Region Stockholm at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bacteriuria Asymptomatic, Urinary Tract Infections
- What is being tested?
- Indwelling urinary catheter
- Type of treatment
- Medical device
- How many people
- 196 participants
- Where
- 2 sitesSweden
- Study dates
- 24 May 2022to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to a rehabilitation clinic for patients ≥ 65 years in Stockholm County, Sweden.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Geriatric Department, Södertälje Hospital
Södertälje
Geriatric Department, Danderyd Hospital
Stockholm
About this study
Official title: The Risk of Symptomatic Bacteriuria and Persistence of Asymptomatic Bacteriuria After Removal of an Indwelling Urinary Catheter- a Prospective Observational Study Among Elderly Inpatients.
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?
- Conditions
- Bacteriuria Asymptomatic, Urinary Tract Infections
- Being tested
- Indwelling urinary catheter
- Keywords
- Urinary Catheter
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indwelling urinary catheterDevice
Removal of indwelling urinary catheter
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Inpatients with an indwelling urinary catheter (IUC) at admission to a rehabilitation clinic for persons ≥65 years in Sweden. Intervention is removal of the IUC. Receives: Device: Indwelling urinary catheter | |
| Control group | Inpatients without an IUC at admission to a rehabilitation clinic for persons ≥65 years in Sweden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic bacteriuria (urinary tract infection)
Clinical diagnosis of urinary tract infection by a physician
Measured: Four weeks
Secondary outcomes (2)
Asymptomatic bacteriuria (ABU)
Prevalence of ABU at the point of removal of an IUC compared with patients without IUC
Measured: One day
Persistence of ABU
For how long does ABU persist after IUC-removal
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start24 May 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacteriuria AsymptomaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ann Tammelin, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039203
- Sponsor's protocol ID
- 2021-02410
- Status last verified
- Nov 2024
- First submitted
- 1 Sep 2021
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kulbay A, Joelsson-Alm E, Amilon K, Tammelin A. Asymptomatic bacteriuria and urinary tract infection in geriatric inpatients after indwelling urinary catheter removal: a descriptive two-centre study. Infect Prev Pract. 2024 Oct 24;6(4):100411. doi: 10.1016/j.infpip.2024.100411. eCollection 2024 Dec.
PubMed 39583881
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Symptomatic Bacteriuria and Persistence of Asymptomatic Bacteriuria After Removal of an Indwelling Urinary Catheter- a Prospective Observational Study Among Elderly Inpatients.
- ClinicalTrials.gov ID
- NCT05039203
- Acronym / sponsor ID
- 2021-02410
- Conditions
- Bacteriuria Asymptomatic, Urinary Tract Infections
- Keywords
- Urinary Catheter
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 24 May 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Device: Indwelling urinary catheterInpatients with an indwelling urinary catheter (IUC) at admission to a rehabilitation clinic for persons ≥65 years in Sweden. Intervention is removal of the IUC. |
| Control group | – | –Inpatients without an IUC at admission to a rehabilitation clinic for persons ≥65 years in Sweden |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to a rehabilitation clinic for patients ≥ 65 years in Stockholm County, Sweden.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indwelling urinary catheterRemoval of indwelling urinary catheter | Device | Intervention group |
Primary outcome
Symptomatic bacteriuria (urinary tract infection)
Time frame: Four weeks
Clinical diagnosis of urinary tract infection by a physician
2 secondary outcomes
Asymptomatic bacteriuria (ABU)
Time frame: One day
Persistence of ABU
Time frame: Four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 39583881Kulbay A, Joelsson-Alm E, Amilon K, Tammelin A. Asymptomatic bacteriuria and urinary tract infection in geriatric inpatients after indwelling urinary catheter removal: a descriptive two-centre study. Infect Prev Pract. 2024 Oct 24;6(4):100411. doi: 10.1016/j.infpip.2024.100411. eCollection 2024 Dec.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteriuria Asymptomatic and Urinary Tract Infections, run by Region Stockholm at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic bacteriuria (urinary tract infection) (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05039203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.