REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection

April 22, 2025 updated by: ecschippers, Leiden University Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eline C. Schippers
  • Phone Number: +31 (0) 6 22776467
  • Email: replace@lumc.nl

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 ZG
        • Recruiting
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older.
  2. An indwelling catheter, either a transurethral or suprapubic catheter, that has been in place for at least 2 weeks.
  3. 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.
  4. 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.
  5. The ability to provide written informed consent for the use of their data.
  6. Sufficient proficiency in the Dutch or English language, both spoken and written, to effectively communicate with the research team and accurately complete the questionnaires.

Exclusion Criteria:

  1. 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)
  2. Expiration of the indication of the indwelling catheter.
  3. Having a planned (routine) catheter replacement during antibiotic therapy.
  4. Contraindications for catheter replacement (judgement treating physician)
  5. Kidney catheters (nephrostomy or double-J catheter).
  6. Needing bladder irrigations because of gross haematuria.
  7. Having bladder stones.
  8. Female patients who are pregnant.
  9. Having a life expectancy of < 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Catheter replacement
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: Catheter replacement

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.
Experimental: Catheter retainment
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.
Procedure: Catheter retainment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 180 days
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.
180 days
Health-related quality of life measured using the PROMIS questionnaires
Time Frame: 90 days
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.
90 days
Health-related quality of life measured using the EQ-5D-5L questionnaire
Time Frame: 180 days
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.
180 days
Time to resolution of CAUTI symptoms
Time Frame: 90 days
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.
90 days
Complications of catheter replacement
Time Frame: 3 days
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.
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
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.
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
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.
90 days and 180 days
Length of hospital stay and ICU-admission during hospital stay
Time Frame: 90 days
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL88486.058.25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After completion of the study, the data sharing plan will be developed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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