Prospective Randomized, Double-blind, Parallel-controlled Versus Placebo in a Polyvalent Sublingual Bacterial Vaccine to 3 Months and 6 Months in Women With RUTI for the Immunomodulatory Efficacy Evaluation, Safety and Clinical Impact

Inmunotek S.L.5 sites in 2 countries240 target enrollmentNovember 2015

ConditionsUrinary Tract Infection Bacterial

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Urinary Tract Infection Bacterial
Sponsor: Inmunotek S.L.
Enrollment: 240
Locations: 5
Primary Endpoint: Decrease in the number of RUTI exacerbations.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

December 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Inmunotek S.L.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Decrease in the number of RUTI exacerbations.

Time Frame: 1 year

Average reduction of RUTI exacerbations

Secondary Outcomes

Severity of RUTI exacerbations(1 year)
First RUTI exacerbation(1 year)
Medication consumption(1 year)
Health resource consumption(1 year)
Number of visits to the emergency service(1 year)
Number of hospitalizations due to RUTI exacerbations(1 year)
Changes from baseline in RUTI Assessment Test(1 year)
Percentage of difference in immunological parameters from baseline to end of the trial(1 year)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability(1 year)