Recurrent Uti
Conditions
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 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.
Interventions
BIOLOGICALUromune
2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
Sponsors
Queen's University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open label
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Responder | 12 months | Participant considered complete responder if no UTI requiring antibiotics reported in the 9 month efficacy period following completion of 3 month vaccine therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of UTI in the Efficacy Period | 12 months | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label Uromune will be taken by the participant for 90 days.
Uromune: 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing. | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Did not return for intervention | 2 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| Age, Continuous | 56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Canada | 64 participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 65 |
| other Total, other adverse events | 9 / 65 |
| serious Total, serious adverse events | 13 / 65 |
Outcome results
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.
Time frame: 12 months
Population: intention to treat participants received at least one dose of vaccine and had first 3-month follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label | Complete Responder | 26 Participants |
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.
Time frame: 12 months
Population: Modified intention to treat included all participants who received at least one dose of vaccine and had first 3-month follow-up visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open Label | Number of UTI in the Efficacy Period | 0.14 Number of UTI/month |