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Uromune in Treating Recurrent Urinary Tract Infections in Women

Primary Purpose

Recurrent Uti

Status

Active

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Uromune

About this trial

This is an interventional prevention trial for Recurrent Uti

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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.

Sites / Locations

Centre for Advanced Urological Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

Uromune will be taken by the participant for 90 days.

Outcomes

Primary Outcome Measures

Complete Responder

Participant considered complete responder if no UTI requiring antibiotics reported 12 months since initiating therapy.

Secondary Outcome Measures

Responder Rate

The number of UTI in individual participants requiring antibiotics in the 12 months after starting therapy will be compared to the number of UTIs requiring antibiotics before therapy is initiated (number over previous 12 months or 2 X the number over the preceding 6 months).

Full Information

NCT ID

NCT04096820

First Posted

September 18, 2019

Last Updated

July 28, 2022

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT04096820

Brief Title

Uromune in Treating Recurrent Urinary Tract Infections in Women

Official Title

Protocol 19-01: Canadian, Single Centre, Pilot, Open Label Study to Evaluate the Efficacy and Safety of the Bacterial Vaccine Uromune in Treating Recurrent Urinary Tract Infections in Women.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 6, 2019 (Actual)

Primary Completion Date

October 31, 2022 (Anticipated)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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 12 months following initiation 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Uti

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Open label

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open Label

Arm Type

Experimental

Arm Description

Uromune will be taken by the participant for 90 days.

Intervention Type

Biological

Intervention Name(s)

Uromune

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete Responder

Description

Participant considered complete responder if no UTI requiring antibiotics reported 12 months since initiating therapy.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Responder Rate

Description

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J. Curtis Nickel, MD, FRCS

Organizational Affiliation

Professor of Urology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Advanced Urological Research

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 3J7

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Uromune in Treating Recurrent Urinary Tract Infections in Women

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