Evaluation of the Efficacy and Safety of MV140
- Conditions
- Urinary Tract Infection Bacterial
- Interventions
- Biological: MV140Biological: Placebo
- Registration Number
- NCT02543827
- Lead Sponsor
- Inmunotek S.L.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MV140 II MV140 The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months Placebo Placebo The subjects will receive daily dose of placebo during 6 month MV140 I MV140 The subjects will receive daily dose of MV140 during 6 months MV140 II Placebo The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months
- Primary Outcome Measures
Name Time Method Decrease in the number of RUTI exacerbations. 1 year Average reduction of RUTI exacerbations
- Secondary Outcome Measures
Name Time Method 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
Health resource consumption 1 year Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures
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
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
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.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability 1 year Review of the number of adverse event per patient
Trial Locations
- Locations (5)
Centro de Salud Capuchinos
🇪🇸Salamanca, Castilla Y LEÓN, Spain
CENTRO DE SALUD de PEÑARANDA
🇪🇸Peñaranda de Bracamonte, Salamanca, Castilla Y LEÓN, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Castilla Y LEÓN, Spain
Royal Berkshire Hospital Nhs Foundation Trust
🇬🇧Reading, London, United Kingdom
Centro de Salud Universidad Centro
🇪🇸Salamanca, Castilla Y LEÓN, Spain