Evaluation of the Efficacy and Safety of MV140

Inmunotek S.L.240 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

240

Conditions

Urinary Tract Infection Bacterial

Interventions

MV140BIOLOGICAL

The subjects will receive daily dose of MV140 during 3 or 6 months

PlaceboBIOLOGICAL

The subjects will receive daily dose of placebo during 3 or 6 months

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (5)

Centro de Salud Universidad Centro

Salamanca, Castille and León, Spain

Centro de Salud Capuchinos

Salamanca, Castille and León, Spain

Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

CENTRO DE SALUD de PEÑARANDA

Peñaranda de Bracamonte, Salamanca, Castilla Y LEÓN, Spain

Outcomes

Primary Outcomes

Decrease in the number of RUTI exacerbations.

Average reduction of RUTI exacerbations

Time frame: 1 year

Secondary Outcomes

Severity of RUTI exacerbations

Review of RUTI exacerbations episodes severity per patient

Time frame: 1 year

First RUTI exacerbation

When takes place the First RUTI exacerbation for every single patient

Time frame: 1 year

Medication consumption

Review of medication consumed from the beginning to the end of the RUTI exacerbation

Time frame: 1 year

Health resource consumption

Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures

Time frame: 1 year

Number of visits to the emergency service

Counting the number of visits to the emergency service due to RUTI exacerbation

Time frame: 1 year

Number of hospitalizations due to RUTI exacerbations

Counting the number of hospitalization days due to RUTI exacerbations

Time frame: 1 year

Changes from baseline in RUTI Assessment Test

Compare the RUTI Assessment Test results at the beginning and at the end of the trial

Time frame: 1 year

Data from ClinicalTrials.gov

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