Catheter-Associated Urinary Tract Infections (CAUTIs)NCT07869992
Evaluate of the Use of Uromune as a Potential Non-antibiotic Prophylactic Strategy for Catheter-associated Urinary Tract Infection in Patients With Long-term Catheterization.
An observational study of Catheter-Associated Urinary Tract Infections (CAUTIs), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
A self-controlled pilot study to evaluate the use of oral bacterial immunotherapy for prevention of catheter-associated urinary tract infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Associated Urinary Tract Infections (CAUTIs)
- What is being tested?
- Uromune
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Oct 2026to 31 Dec 2027
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with long-term indwelling Foley catheter with at least one documented catheter-associated urinary tract infection episode or hospital admission for suspected urinary tract infection in the preceding 6 months.
Who may be able to join
- Adults aged ≥18 years
- Long-term indwelling Foley catheter (≥4 weeks prior to enrolment)
- Expected to remain catheterized for ≥6 months
- At least one documented CAUTI episode or hospital admission for suspected UTI in the preceding 6 months
Who cannot join
- Planned catheter removal within 6 months
- Ongoing systemic infection at enrolment
- Immunosuppression state including:
- Primary immunodeficiency - Systemic immunosuppressive therapy e.g. steroid, chemotherapy, biologics, or immunosuppressants - Known HIV carrier or AIDS patient
- Known hypersensitivity to components of Uromune
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Prince of Wales Hospital
Hong Kong
Alex Qinyang LIU, MBBS, MSc, FRCSEd, +852 35052625, alexliu@surgery.cuhk.edu.hk
About this study
Official title: Oral Bacterial Immunotherapy (Uromune) in Long-term Indwelling Foley Catheter Patients: a Self-controlled Pilot Study for Prevention of Catheter-associated Urinary Tract Infection (CAUTI) With Microbiome and Immune Correlates
A self-controlled pilot study to evaluate the use of oral bacterial immunotherapy for prevention of catheter-associated urinary tract infection.
Read the detailed description
The aim of the study is to prospectively evaluate Uromune as a potential non-antibiotic prophylactic strategy for catheter-associated urinary tract infection in patients with long-term catheterization.
- Being tested
- Uromune
- Keywords
- Oral bacterial immunotherapy, Uromune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UromuneDrug
Oral bacterial immunotherapy (Sublingual Vaccine Uromune) MV140
| Study group | Role | What they receive |
|---|---|---|
| Uromune | Standard treatment course: oral bacterial immunotherapy (Sublingual Vaccine Uromune) MV140 Receives: Drug: Uromune |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in total number of symptomatic catheter-associated urinary tract infection (CAUTI) requiring hospital admission
By comparing the total number of symptomatic catheter-associated urinary tract infection (CAUTI) requiring hospital admission during the 6-month post-intervention period and the 6-month pre-intervention period.
Measured: 6-month post-intervention period compared with the 6-month pre-intervention period
Secondary outcomes (7)
Difference in total number of emergency department visits for suspected UTI or urosepsis
By comparing the total number of emergency department visits for suspected UTI or urosepsis during the 6-month post-intervention period and the 6-month pre-intervention period.
Measured: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of antibiotic courses
By comparing the total number of antibiotic courses during the 6-month post-intervention period and the 6-month pre-intervention period.
Measured: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of antibiotic days of therapy
By comparing the total number of antibiotic days of therapy during the 6-month post-intervention period and the 6-month pre-intervention period.
Measured: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in time to first CAUTI admission
By comparing the time to first catheter-associated urinary tract infection admission during the 6-month post-intervention period and the 6-month pre-intervention period.
Measured: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of unplanned catheter changes or catheter blockage events
By comparing the total number of unplanned catheter changes or catheter blockage events during the 6-month post-intervention period and the 6-month pre-intervention period.
Measured: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of all-cause hospital admissions
By comparing the total number of all-cause hospital admissions during the 6-month post-intervention period and the 6-month pre-intervention period.
Measured: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of adverse events related to immunotherapy
By comparing the total number of adverse events related to immunotherapy during the 6-month post-intervention period and the 6-month pre-intervention period.
Measured: 6-month post-intervention period compared with the 6-month pre-intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Catheter-Associated Urinary Tract Infections (CAUTIs)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Qinyang Liu, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869992
- Sponsor's protocol ID
- CRE 2026.191
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Hernandez-Sanchez JE, Lorenzo-Gomez MF, Gonzalez-Enguita C. Current Evidence on Safety, Efficacy and Efficiency of Sublingual Vaccine Uromune(R) in Prevention of Recurrent Urinary Tract Infections: A Literature Review. Pathogens. 2025 Dec 30;15(1):42. doi: 10.3390/pathogens15010042.
PubMed 41599026Saz-Leal P, Ligon MM, Diez-Rivero CM, Garcia-Ayuso D, Mohanty S, Vinuela M, Real-Arevalo I, Conejero L, Brauner A, Subiza JL, Mysorekar IU. MV140 Mucosal Vaccine Induces Targeted Immune Response for Enhanced Clearance of Uropathogenic E. coli in Experimental Urinary Tract Infection. Vaccines (Basel). 2024 May 14;12(5):535. doi: 10.3390/vaccines12050535.
PubMed 38793786Nickel JC, Doiron RC. An Effective Sublingual Vaccine, MV140, Safely Reduces Risk of Recurrent Urinary Tract Infection in Women. Pathogens. 2023 Feb 21;12(3):359. doi: 10.3390/pathogens12030359.
PubMed 36986281
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Bacterial Immunotherapy (Uromune) in Long-term Indwelling Foley Catheter Patients: a Self-controlled Pilot Study for Prevention of Catheter-associated Urinary Tract Infection (CAUTI) With Microbiome and Immune Correlates
- ClinicalTrials.gov ID
- NCT07869992
- Acronym / sponsor ID
- CRE 2026.191
- Keywords
- Oral bacterial immunotherapy, Uromune
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (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.
A self-controlled pilot study to evaluate the use of oral bacterial immunotherapy for prevention of catheter-associated urinary tract infection.
Detailed description
The aim of the study is to prospectively evaluate Uromune as a potential non-antibiotic prophylactic strategy for catheter-associated urinary tract infection in patients with long-term catheterization.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uromune | – | Drug: UromuneStandard treatment course: oral bacterial immunotherapy (Sublingual Vaccine Uromune) MV140 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with long-term indwelling Foley catheter with at least one documented catheter-associated urinary tract infection episode or hospital admission for suspected urinary tract infection in the preceding 6 months.
Key inclusion criteria (4 listed)
- Adults aged ≥18 years
- Long-term indwelling Foley catheter (≥4 weeks prior to enrolment)
- Expected to remain catheterized for ≥6 months
- At least one documented CAUTI episode or hospital admission for suspected UTI in the preceding 6 months
Key exclusion criteria (5 listed)
- Planned catheter removal within 6 months
- Ongoing systemic infection at enrolment
- Immunosuppression state including:
- Known hypersensitivity to components of Uromune
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 |
|---|---|---|
| UromuneOral bacterial immunotherapy (Sublingual Vaccine Uromune) MV140 | Drug | Uromune |
Primary outcome
Difference in total number of symptomatic catheter-associated urinary tract infection (CAUTI) requiring hospital admission
Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period
By comparing the total number of symptomatic catheter-associated urinary tract infection (CAUTI) requiring hospital admission during the 6-month post-intervention period and the 6-month pre-intervention period.
7 secondary outcomes
Difference in total number of emergency department visits for suspected UTI or urosepsis
Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of antibiotic courses
Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of antibiotic days of therapy
Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in time to first CAUTI admission
Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of unplanned catheter changes or catheter blockage events
Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of all-cause hospital admissions
Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period
Difference in total number of adverse events related to immunotherapy
Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period
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 13 Oct 2026.
- Background: PubMed 41599026Hernandez-Sanchez JE, Lorenzo-Gomez MF, Gonzalez-Enguita C. Current Evidence on Safety, Efficacy and Efficiency of Sublingual Vaccine Uromune(R) in Prevention of Recurrent Urinary Tract Infections: A Literature Review. Pathogens. 2025 Dec 30;15(1):42. doi: 10.3390/pathogens15010042.
- Background: PubMed 38793786Saz-Leal P, Ligon MM, Diez-Rivero CM, Garcia-Ayuso D, Mohanty S, Vinuela M, Real-Arevalo I, Conejero L, Brauner A, Subiza JL, Mysorekar IU. MV140 Mucosal Vaccine Induces Targeted Immune Response for Enhanced Clearance of Uropathogenic E. coli in Experimental Urinary Tract Infection. Vaccines (Basel). 2024 May 14;12(5):535. doi: 10.3390/vaccines12050535.
- Background: PubMed 36986281Nickel JC, Doiron RC. An Effective Sublingual Vaccine, MV140, Safely Reduces Risk of Recurrent Urinary Tract Infection in Women. Pathogens. 2023 Feb 21;12(3):359. doi: 10.3390/pathogens12030359.
- Individual participant dataSharing planned: Undecided
Related trials for Catheter-Associated Urinary Tract Infections (CAUTIs)
Active, not recruiting
Early (Postoperative Day 3) Versus Standard (Postoperative Day 6) Urethral Catheter Removal After Living Donor Kidney Transplantation
Catheter-Associated Urinary Tract Infections (CAUTIs), Kidney Transplantation
Not yet recruitingObservational study
Antibiofilm Activity of Chitosan Nanoparticles Against Uropathogenic Escherichia Coli
Urinary Tract Infections (UTIs), Catheter-Associated Urinary Tract Infections (CAUTIs)
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?
An observational study of Catheter-Associated Urinary Tract Infections (CAUTIs), run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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 Hong Kong. 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 Alex Qinyang LIU, MBBS, MSc, FRCSEd (+852 35052625, alexliu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in total number of symptomatic catheter-associated urinary tract infection (CAUTI) requiring hospital admission (time frame: 6-month post-intervention period compared with the 6-month pre-intervention period). 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 NCT07869992, which also lists 3 linked publications.
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 13 Oct 2026.