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Uromune in Treating Recurrent Urinary Tract Infections in Women

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ClinicalTrials.gov Identifier: NCT04096820
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. J. Curtis Nickel, Queen's University

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

Condition or disease Intervention/treatment Phase
Recurrent Uti Biological: Uromune Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label
Uromune will be taken by the participant for 90 days.
Biological: Uromune
2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.




Primary Outcome Measures :
  1. Complete Responder [ Time Frame: 12 months ]
    Participant considered complete responder if no UTI requiring antibiotics reported 12 months since initiating therapy.


Secondary Outcome Measures :
  1. Responder Rate [ Time Frame: 12 months ]
    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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096820


Contacts
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Contact: Janet Clark-Pereira 613-548-7805 jmc2@queensu.ca
Contact: J. Curtis Nickel, MD, FRCSC 613-548-2497 jcn@queensu.ca

Locations
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Canada, Ontario
Centre for Advanced Urological Research Recruiting
Kingston, Ontario, Canada, K7L 3J7
Contact: Janet Clark-Pereira    (613) 548-7805    jmc2@queensu.ca   
Principal Investigator: J. Curtis Nickel, MD FRCSC         
Sub-Investigator: Chris Doiron, MD         
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: J. Curtis Nickel, MD, FRCS Professor of Urology
  Study Documents (Full-Text)

Documents provided by Dr. J. Curtis Nickel, Queen's University:
Informed Consent Form  [PDF] August 15, 2019


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Responsible Party: Dr. J. Curtis Nickel, Professor or Urology, Queen's University
ClinicalTrials.gov Identifier: NCT04096820     History of Changes
Other Study ID Numbers: 6026618
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases