Uromune in Treating Recurrent Urinary Tract Infections in Women

NCT04096820 | Terminated Phase 2 Results DMC

• 1 other identifier: 6026618
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Uti

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of UTI in the Efficacy Period

  12 months

Study Arms (1)

Open Label

EXPERIMENTAL

Uromune will be taken by the participant for 90 days.

Biological: Uromune

Interventions

Uromune BIOLOGICAL

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

Open Label

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 Uromune® 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.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Centre for Advanced Urological Research

Kingston, Ontario, K7L 3J7, Canada

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

uromune

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Heather McFarlane, Administrative Assistant
• Organization: Queen's University/Kingston General Health Research Institute

heather.mcfarlane@kingstonhsc.ca

613-549-6666

Study Officials

• J. Curtis Nickel, MD, FRCS

  Professor of Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor or Urology

Model Details: Open label

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: September 6, 2019
• Primary Completion: October 31, 2022
• Study Completion: January 1, 2023
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Locations

CA (1)