Urinary Tract Infection Bacterial
Conditions
Keywords
Vaccine, Recurrent Urinary Tract Infections (RUTI)
Brief summary
The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo group.
Detailed description
Double blind parallel placebo controlled study. The subjects will receive medication during three or six months and will be followed up during another twelve months.
Interventions
BIOLOGICALMV140
The subjects will receive daily dose of MV140 during 3 or 6 months
BIOLOGICALPlacebo
The subjects will receive daily dose of placebo during 3 or 6 months
Sponsors
Inmunotek S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Women who gave their informed consent. * Age between 18 and 75 years. * Must be able to meet the dosage regimen. * Subjects who had had at least 5 episodes of cystitis in the last 12 months. * Subjects who had not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis. * Subjects who were free of urinary tract infections at the time of inclusion in the study.
Exclusion criteria
* Had not given their informed consent. * Age was not within the established age range. * Could not offer cooperation and/or had severe psychiatric disorders. * Presented a pathologic post-micturition residue. * Presented moderate to severe incontinence. * Presented genital tumours. * Presented Urinary tract tumours. * Presented lithiasis. * Presented alterations in the immune system. * Presented complicated UTIs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in the number of RUTI exacerbations. | 1 year | Average reduction of RUTI exacerbations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of difference in immunological parameters from baseline to end of the trial | 1 year | Compare the changes from specific cell proliferation baseline against antigens of the vaccine. |
| Severity of RUTI exacerbations | 1 year | Review of RUTI exacerbations episodes severity per patient |
| First RUTI exacerbation | 1 year | When takes place the First RUTI exacerbation for every single patient |
| Medication consumption | 1 year | Review of medication consumed from the beginning to the end of the RUTI exacerbation |
| Changes from baseline in RUTI Assessment Test | 1 year | Compare the RUTI Assessment Test results at the beginning and at the end of the trial |
| Number of visits to the emergency service | 1 year | Counting the number of visits to the emergency service due to RUTI exacerbation |
| Number of hospitalizations due to RUTI exacerbations | 1 year | Counting the number of hospitalization days due to RUTI exacerbations |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 1 year | Review of the number of adverse event per patient |
| Health resource consumption | 1 year | Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures |
Countries
Spain, United Kingdom
Outcome results
None listed