Catheter Associated Urinary Tract InfectionNCT06936631
REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
A study testing Catheter replacement and Catheter retainment in people with Catheter Associated Urinary Tract Infection, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
With this project the investigators aim to address the following question: "Is it beneficial to change bladder catheters during urinary tract infections?" There is debate regarding the usefulness of changing an indwelling catheter during antibiotic treatment of a catheter-associated urinary tract infection (CAUTI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Associated Urinary Tract Infection
- What is being tested?
- Catheter replacement and Catheter retainment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2025to Feb 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- An indwelling catheter, either a transurethral or suprapubic catheter, that has been in place for at least 2 weeks.
- At least one CAUTI-related symptom, defined according to the IDSA guideline (11): onset or worsening of fever (> 38 degrees), rigors, altered mental status, malaise or lethargy with no other identified cause, flank pain, costovertebral angle tenderness, acute haematuria, pelvic discomfort, or suprapubic pain/tenderness. In patients with spinal cord injury, increased spasticity, autonomic dysreflexia, or sense of unease are also compatible with CAUTI.
- Urine culture with ≥ 103 colony-forming units (CFU)/mL of ≥ 1 bacterial species, or urine culture with <103 CFU/mL along with a positive blood culture with the same microorganism as the urine culture.
- The ability to provide written informed consent for the use of their data.
- Sufficient proficiency in the Dutch or English language, both spoken and written, to effectively communicate with the research team and accurately complete the questionnaires.
Who cannot join
- Having an immunodeficiency: High-dose corticosteroid use (any equivalent of ≥ 20 mg prednisolone per day for > 4 weeks), severe primary immunodeficiency, organ transplant, neutropenia (absolute neutrophil count < 0.50 x 10⁹/L)
- Expiration of the indication of the indwelling catheter.
- Having a planned (routine) catheter replacement during antibiotic therapy.
- Contraindications for catheter replacement (judgement treating physician)
- Kidney catheters (nephrostomy or double-J catheter).
- Needing bladder irrigations because of gross haematuria.
Show all 9Show fewer
- Having bladder stones.
- Female patients who are pregnant.
- Having a life expectancy of < 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333 ZG
About this study
Official title: REPLACE: the Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
With this project the investigators aim to address the following question: "Is it beneficial to change bladder catheters during urinary tract infections?" There is debate regarding the usefulness of changing an indwelling catheter during antibiotic treatment of a catheter-associated urinary tract infection (CAUTI). The current guideline recommends catheter replacement, but is based on limited evidence. Our hypothesis is that there is no added value for patients to change the catheter during an antibiotic treatment for CAUTI. If refraining from catheter replacement is non inferior, this would result in a reduction of invasive procedures and reduction of healthcare associated costs. Patients with CAUTI and an indication for antibiotic treatment will be randomized to catheter replacement or no catheter replacement. The study will be conducted in academic and non-academic hospitals in The Netherlands. 300 patients will need to be included.
Read the detailed description
As a result of the widespread application of urinary catheterization, catheter-associated urinary tract infection (CAUTI) is the most common healthcare associated infection. To fasten recovery and reduce the risk of a recurrent CAUTI, current guidelines recommend to replace the catheter at the onset of a CAUTI when the indwelling catheter has been in place for more than 2 weeks. This recommendation, however, is based on limited evidence. Additionally, there is significant practice variation in the Netherlands regarding catheter replacement in CAUTI. Given the limited evidence and significant practice variation in the Netherlands, this Randomized Controlled Trial including 300 CAUTI patients is needed.
The main question this study aims to answer is whether not changing the urinary catheter (catheter retainment) during a catheter-associated urinary tract infection (CAUTI) is non-inferior to catheter replacement in terms of the risk of a recurrent CAUTI within 90 days. Secondary objectives include 30-day mortality, health-related quality of life, time to resolution of CAUTI symptoms, complications of catheter replacement (e.g., discomfort, bleeding, sepsis) and healthcare and societal costs.
In the intervention group there will be no catheter replacement during CAUTI, meaning there will be no catheter replacement during the entire course of antibiotic treatment. In this group, catheter replacement will follow the patients regular replacement schedule, consequently meaning that it occurs outside the duration of the antibiotic treatment . The duration of antibiotic treatment is 10 days for both men and women. The control group follows the current guidelines. In this group, the catheter will be replaced within 3 days after the start of antibiotic therapy.
- Being tested
- Catheter replacement, Catheter retainment
- Keywords
- Catheter associated urinary tract infection, CAUTI, Urinary tract infection, UTI, Indwelling catheter, Urosepsis
- 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.
Catheter replacementProcedure or surgery
In the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule.
The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results.
Catheter retainmentProcedure or surgery
In the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule. The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results.
| Study group | Role | What they receive |
|---|---|---|
| Catheter replacement | Other | The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. Receives: Procedure: Catheter replacement |
| Catheter retainment | Experimental | In the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard careguidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule. Receives: Procedure: Catheter retainment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent CAUTI within 90 days post-antibiotic treatment (T0 is the start of antibiotic treatment)
The definition of a recurrent CAUTI is identical to the definition used for inclusion. The pathogen does not have to be identical to the causative pathogen that was identified during the first episode. In case of a suspected recurrence, the following data will be collected: signs and symptoms, GCS, qSOFA, laboratory results, admission, antimicrobial treatment and treatment duration.
Measured: 90 days
Secondary outcomes (8)
Mortality
One of the secondary outcomes is 30-day mortality. However, if a patient passes away during the entire course of the study (180 days), this will be recorded.
Measured: 180 days
Health-related quality of life measured using the PROMIS questionnaires
Health-related quality of life will be measured using the Patient-Reported Outcomes Measurement Information System Scale (PROMIS). This will measure various aspects of physical, mental, and social health. The PROMIS questionnaire will be administered at different times from baseline, to 90 days: baseline, day 3, day 7, day 28 and day 90.
Measured: 90 days
Health-related quality of life measured using the EQ-5D-5L questionnaire
Health-related quality of life will be measured using the EQ-5D-5L questionnaire which assesses five dimensions of health-related quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The questionnaire will be administered at different times, from baseline, to 180 days: baseline, day 3, day 7, day 14, day 28, day 90 and day 180.
Measured: 180 days
Time to resolution of CAUTI symptoms
After inclusion, patients are provided with a diary, in which they record their (CAUTI) symptoms. Additionally, the CAUTI-related symptoms are monitored by telephone at 3 days and then weekly from the start of antibiotic treatment until complete resolution of symptoms. Monthly telephone visits will also be conducted for optimal monitoring of recurrences, until the primary endpoint of 90 days.
Measured: 90 days
Complications of catheter replacement
Complications of either catheter replacement or retainment and the severity of the complications will be recorded from the moment the procedure has taken place. A few examples of complications are discomfort, bleeding or sepsis. Considering the 3-day timespan between antibiotic initiation and catheter replacement, complications will be administered at 3 days.
Measured: 3 days
Healthcare costs using a selection of items relevant for this population of the medical consumption (iMCQ) questionnaire
Healthcare costs consist of the costs of the catheter replacement and other healthcare use of the patients. Cost of catheter replacement will be assessed using the micro costing approach in hospital setting. Other healthcare use (e.g. hospital days, cost of medication, outpatient visits, general practitioners visits, homecare visits) will be based on the iMCQ questionnaire administered to patients after 12 weeks and 6 months consisting of a selection of items relevant for this population.
Measured: 90 days and 180 days
Societal costs using a selection of items relevant for this population of the productivity (iPCQ) questionnaire
Societal costs consisting of productivity losses in paid and unpaid work will be assessed using the iPCQ questionnaire administered to patients after 12 weeks and 6 months consisting of a selection of items of the relevant for this population.
Measured: 90 days and 180 days
Length of hospital stay and ICU-admission during hospital stay
If the patient presented at the hospital, it will be recorded whether admission occurred, and if so, whether the patient was admitted to a general ward or the intensive care unit. Additionally, if the patient is initially admitted to a general ward and subsequently transferred to the intensive care unit, this transfer will also be documented. The duration of the patient's admission will be recorded.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (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 Catheter Associated Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ecschippers, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936631
- Sponsor's protocol ID
- NL88486.058.25
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study, the data sharing plan will be developed.
Publications
Schippers E, van Uhm J, Wilmsen M, Tigchelaar A, Rozemeijer W, Schout B, van den Akker-van Marle E, van der Beek M, Kummeling M, Groenwold R, Geerlings S, Lambregts M; REPLACE study group. The impact of catheter replacement in patients with catheter-associated urinary tract infection: study protocol paper for a multicentre, non-inferiority randomized controlled trial (REPLACE). BMC Infect Dis. 2026 Feb 27;26(1):709. doi: 10.1186/s12879-026-12890-x.
PubMed 41761084
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPLACE: the Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT06936631
- Acronym / sponsor ID
- NL88486.058.25
- Keywords
- Catheter associated urinary tract infection, CAUTI, Urinary tract infection, UTI, Indwelling catheter, Urosepsis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 20 Apr 2025 (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.
With this project the investigators aim to address the following question: "Is it beneficial to change bladder catheters during urinary tract infections?" There is debate regarding the usefulness of changing an indwelling catheter during antibiotic treatment of a catheter-associated urinary tract infection (CAUTI). The current guideline recommends catheter replacement, but is based on limited evidence. Our hypothesis is that there is no added value for patients to change the catheter during an antibiotic treatment for CAUTI. If refraining from catheter replacement is non inferior, this would result in a reduction of invasive procedures and reduction of healthcare associated costs. Patients with CAUTI and an indication for antibiotic treatment will be randomized to catheter replacement or no catheter replacement. The study will be conducted in academic and non-academic hospitals in The Netherlands. 300 patients will need to be included.
Detailed description
As a result of the widespread application of urinary catheterization, catheter-associated urinary tract infection (CAUTI) is the most common healthcare associated infection. To fasten recovery and reduce the risk of a recurrent CAUTI, current guidelines recommend to replace the catheter at the onset of a CAUTI when the indwelling catheter has been in place for more than 2 weeks. This recommendation, however, is based on limited evidence. Additionally, there is significant practice variation in the Netherlands regarding catheter replacement in CAUTI. Given the limited evidence and significant practice variation in the Netherlands, this Randomized Controlled Trial including 300 CAUTI patients is needed.
The main question this study aims to answer is whether not changing the urinary catheter (catheter retainment) during a catheter-associated urinary tract infection (CAUTI) is non-inferior to catheter replacement in terms of the risk of a recurrent CAUTI within 90 days. Secondary objectives include 30-day mortality, health-related quality of life, time to resolution of CAUTI symptoms, complications of catheter replacement (e.g., discomfort, bleeding, sepsis) and healthcare and societal costs.
In the intervention group there will be no catheter replacement during CAUTI, meaning there will be no catheter replacement during the entire course of antibiotic treatment. In this group, catheter replacement will follow the patients regular replacement schedule, consequently meaning that it occurs outside the duration of the antibiotic treatment . The duration of antibiotic treatment is 10 days for both men and women. The control group follows the current guidelines. In this group, the catheter will be replaced within 3 days after the start of antibiotic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter replacement | Other | Procedure: Catheter replacementThe control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. |
| Catheter retainment | Experimental | Procedure: Catheter retainmentIn the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard careguidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older.
- An indwelling catheter, either a transurethral or suprapubic catheter, that has been in place for at least 2 weeks.
- At least one CAUTI-related symptom, defined according to the IDSA guideline (11): onset or worsening of fever (> 38 degrees), rigors, altered mental status, malaise or lethargy with no other identified cause, flank pain, costovertebral angle tenderness, acute haematuria, pelvic discomfort, or suprapubic pain/tenderness. In patients with spinal cord injury, increased spasticity, autonomic dysreflexia, or sense of unease are also compatible with CAUTI.
- Urine culture with ≥ 103 colony-forming units (CFU)/mL of ≥ 1 bacterial species, or urine culture with <103 CFU/mL along with a positive blood culture with the same microorganism as the urine culture.
- The ability to provide written informed consent for the use of their data.
Key exclusion criteria (9 listed)
- Having an immunodeficiency: High-dose corticosteroid use (any equivalent of ≥ 20 mg prednisolone per day for > 4 weeks), severe primary immunodeficiency, organ transplant, neutropenia (absolute neutrophil count < 0.50 x 10⁹/L)
- Expiration of the indication of the indwelling catheter.
- Having a planned (routine) catheter replacement during antibiotic therapy.
- Contraindications for catheter replacement (judgement treating physician)
- Kidney catheters (nephrostomy or double-J catheter).
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 |
|---|---|---|
| Catheter replacementIn the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule. The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. | Procedure or surgery | Catheter replacement |
| Catheter retainmentIn the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule. The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. | Procedure or surgery | Catheter retainment |
Primary outcome
Recurrent CAUTI within 90 days post-antibiotic treatment (T0 is the start of antibiotic treatment)
Time frame: 90 days
The definition of a recurrent CAUTI is identical to the definition used for inclusion. The pathogen does not have to be identical to the causative pathogen that was identified during the first episode. In case of a suspected recurrence, the following data will be collected: signs and symptoms, GCS, qSOFA, laboratory results, admission, antimicrobial treatment and treatment duration.
8 secondary outcomes
Mortality
Time frame: 180 days
Health-related quality of life measured using the PROMIS questionnaires
Time frame: 90 days
Health-related quality of life measured using the EQ-5D-5L questionnaire
Time frame: 180 days
Time to resolution of CAUTI symptoms
Time frame: 90 days
Complications of catheter replacement
Time frame: 3 days
Healthcare costs using a selection of items relevant for this population of the medical consumption (iMCQ) questionnaire
Time frame: 90 days and 180 days
Societal costs using a selection of items relevant for this population of the productivity (iPCQ) questionnaire
Time frame: 90 days and 180 days
Length of hospital stay and ICU-admission during hospital stay
Time frame: 90 days
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 27 Apr 2025.
- Derived from this study: PubMed 41761084Schippers E, van Uhm J, Wilmsen M, Tigchelaar A, Rozemeijer W, Schout B, van den Akker-van Marle E, van der Beek M, Kummeling M, Groenwold R, Geerlings S, Lambregts M; REPLACE study group. The impact of catheter replacement in patients with catheter-associated urinary tract infection: study protocol paper for a multicentre, non-inferiority randomized controlled trial (REPLACE). BMC Infect Dis. 2026 Feb 27;26(1):709. doi: 10.1186/s12879-026-12890-x.
- Individual participant dataSharing planned: Yes. After completion of the study, the data sharing plan will be developed.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter replacement and Catheter retainment in people with Catheter Associated Urinary Tract Infection, run by Leiden University Medical Center at 1 site in Netherlands.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Contact Eline C. Schippers (+31 (0) 6 22776467, replace@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent CAUTI within 90 days post-antibiotic treatment (T0 is the start of antibiotic treatment) (time frame: 90 days). 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 NCT06936631, 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 27 Apr 2025.