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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.

ConditionCatheter-Associated Urinary Tract Infections (CAUTIs)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

A self-controlled pilot study to evaluate the use of oral bacterial immunotherapy for prevention of catheter-associated urinary tract infection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Planned catheter removal within 6 months

Ongoing systemic infection at enrolment

Known hypersensitivity to components of Uromune

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Uromune

    Drug

    Oral bacterial immunotherapy (Sublingual Vaccine Uromune) MV140

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Uromune1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: