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Not yet recruitingNCT07869992Updated Oct 13, 2026

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 in Catheter-Associated Urinary Tract Infections (CAUTIs), sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Chinese University of Hong Kong · Observational

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Catheter-Associated Urinary Tract Infections (CAUTIs)

Keywords

  • Oral bacterial immunotherapy
  • Uromune
03

In context

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Uromune

    Standard treatment course: oral bacterial immunotherapy (Sublingual Vaccine Uromune) MV140

    Drug: Uromune

Interventions

  • DrugUromune

    Oral bacterial immunotherapy (Sublingual Vaccine Uromune) MV140

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period

Secondary outcomes

  1. 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.

    Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period

  2. 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.

    Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period

  3. 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.

    Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period

  4. 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.

    Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period

  5. 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.

    Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period

  6. 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.

    Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period

  7. 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.

    Time frame: 6-month post-intervention period compared with the 6-month pre-intervention period

07

Study locations

1 site
  • Prince of Wales Hospital
    Hong Kong, Hong Kong
08

References and documents

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 41599026 ↗
  • Saz-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 38793786 ↗
  • Nickel 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869992
Responsible party
Alex Qinyang Liu (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Alex Qinyang LIU, MBBS, MSc, FRCSEd
Contact
alexliu@surgery.cuhk.edu.hk
+852 35052625
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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