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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04096820
Other study ID # 6026618
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 6, 2019
Est. completion date January 1, 2023

Study information

Verified date May 2024
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the effectiveness and safety of the vaccine Uromune in Canadian women with recurrent urinary tract infection.


Description:

The proposal is for a real life clinical practice study in which female participants with a predefined history of recurrent UTIs in the previous year will be treated with 3 months of oral vaccine with a further 9 months of follow-up. The primary outcome will be no UTI in the 9 month efficacy period following completion of the vaccine (definition of a responder). A clinically significant and important outcome will be defined as a responder rate of 50% (50% of participants who had at least 3 UTIs in the previous year reporting no UTIs after therapy initiated.


Recruitment information / eligibility

Status Terminated
Enrollment 67
Est. completion date January 1, 2023
Est. primary completion date October 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Can provide written consent and willingness to comply with all aspects of study treatment and study requirements. - Individuals who have had at least 3 episodes of a UTI in the past 12 months or 2 UTI episodes in the past 6 months. At least one of the UTI episodes must be associated with a positive urine culture with a traditional uropathogen including Escherichia coli, Proteus spp. Staphyloccous sp. Enterococcus sp. Klebsiella sp. or Pseudomonas aeruginosa. - Post-menopausal for a minimum of 1 year or negative pregnancy test if participant is of child bearing potential and agreement to acceptable contraceptive use from Screening Visit 1 to final follow up visit if participant is sexually active. Medically acceptable methods of contraception include hormonal contraception (i.e. estrogen, and/or progesterone or preparations that contain a combination of these hormones), non-hormonal intrauterine device or double barrier method (i.e. condom with foam or vaginal spermicidal suppository, or diaphragm with spermicide) or vasectomy of sole sexual partner. Complete abstinence alone can be used as a method of contraception. - Free of a urinary tract infection at the time of trial inclusion. Exclusion Criteria: - History of bladder tumours including uterine, cervical, vaginal or urethral cancer. - Worrisome post-voiding residual (investigator's discretion). - Infection related to urinary lithiasis. - Any immunological disease requiring active therapy. - Currently receiving Immunotherapy. - Taking any prophylactic antibiotics at screening. Any prophylactic antibiotics must be stopped the day of the screening visit. - Any known intolerance to the ingredients of the UromuneĀ® Immunotherapy. - Have any other condition or disease which, in the opinion of the investigator, could compromise participant safety or interfere with the participant's participation in the study or in the evaluation of the study results.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Uromune
2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.

Locations

Country Name City State
Canada Centre for Advanced Urological Research Kingston Ontario

Sponsors (1)

Lead Sponsor Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Responder Participant considered complete responder if no UTI requiring antibiotics reported in the 9 month efficacy period following completion of 3 month vaccine therapy. 12 months
Secondary Number of UTI in the Efficacy Period The number of UTI in individual participants requiring antibiotics in the 9 month efficacy period following completion of vaccine therapy will be compared to the number of UTIs requiring antibiotics before therapy is initiated. 12 months
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