Uromune in Treating Recurrent Urinary Tract Infections in Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04096820|
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Uti||Biological: Uromune||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label|
|Masking:||None (Open Label)|
|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|
Experimental: Open Label
Uromune will be taken by the participant for 90 days.
2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
- Complete Responder [ Time Frame: 12 months ]Participant considered complete responder if no UTI requiring antibiotics reported 12 months since initiating therapy.
- 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).
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
|Contact: Janet Clark-Pereirafirstname.lastname@example.org|
|Contact: J. Curtis Nickel, MD, FRCSCemail@example.com|
|Centre for Advanced Urological Research||Recruiting|
|Kingston, Ontario, Canada, K7L 3J7|
|Contact: Janet Clark-Pereira (613) 548-7805 firstname.lastname@example.org|
|Principal Investigator: J. Curtis Nickel, MD FRCSC|
|Sub-Investigator: Chris Doiron, MD|
|Principal Investigator:||J. Curtis Nickel, MD, FRCS||Professor of Urology|