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Trial record 57 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Evaluation of the Efficacy and Safety of MV140 (MV140)

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ClinicalTrials.gov Identifier: NCT02543827
Recruitment Status : Recruiting
First Posted : September 7, 2015
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Bacterial Biological: MV140 Biological: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MV140 I
The subjects will receive daily dose of MV140 during 6 months
Biological: MV140
The subjects will receive daily dose of MV140 during 3 or 6 months

Experimental: MV140 II
The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months
Biological: MV140
The subjects will receive daily dose of MV140 during 3 or 6 months

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

Placebo Comparator: Placebo
The subjects will receive daily dose of placebo during 6 month
Biological: Placebo
The subjects will receive daily dose of placebo during 3 or 6 months




Primary Outcome Measures :
  1. Decrease in the number of RUTI exacerbations. [ Time Frame: 1 year ]
    Average reduction of RUTI exacerbations


Secondary Outcome Measures :
  1. Severity of RUTI exacerbations [ Time Frame: 1 year ]
    Review of RUTI exacerbations episodes severity per patient

  2. First RUTI exacerbation [ Time Frame: 1 year ]
    When takes place the First RUTI exacerbation for every single patient

  3. Medication consumption [ Time Frame: 1 year ]
    Review of medication consumed from the beginning to the end of the RUTI exacerbation

  4. Health resource consumption [ Time Frame: 1 year ]
    Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures

  5. Number of visits to the emergency service [ Time Frame: 1 year ]
    Counting the number of visits to the emergency service due to RUTI exacerbation

  6. Number of hospitalizations due to RUTI exacerbations [ Time Frame: 1 year ]
    Counting the number of hospitalization days due to RUTI exacerbations

  7. Changes from baseline in RUTI Assessment Test [ Time Frame: 1 year ]
    Compare the RUTI Assessment Test results at the beginning and at the end of the trial

  8. Percentage of difference in immunological parameters from baseline to end of the trial [ Time Frame: 1 year ]
    Compare the changes from specific cell proliferation baseline against antigens of the vaccine.

  9. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year ]
    Review of the number of adverse event per patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gave written informed consent.
  • Women
  • Aged between 18 and 75 years.
  • They must be able to meet the dosing regimen.
  • Individuals who have had at least 3 episodes of cystitis in the past 12 months.
  • Subject that does not have responded to health and hygiene measures and/or suppressive treatments and/or postcoital prophylaxis.

Exclusion Criteria:

  • Not have granted the informed written consent.
  • Not included in the established age range.
  • Not to offer cooperation I have serious psychiatric disorders.
  • Present pathological post-voiding residue.
  • Submit moderada-grave incontinence.
  • Present genital tumors.
  • Suffering from urinary tract tumors.
  • Submit lithiasis.
  • Present alterations in the immune system.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543827


Contacts
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Contact: Fernanda Lorenzo, PhD; MD +34923 294 400
Contact: Miguel Casanovas, PhD; MD 3434916510010 mcasanovas@inmunotek.com

Locations
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Spain
Centro de Salud Universidad Centro Recruiting
Salamanca, Castilla Y LEÓN, Spain, 37001
Contact: Isidoro Martín, MD    +34923 21 99 11      
Principal Investigator: Isidoro Martín, MD         
Centro de Salud Capuchinos Recruiting
Salamanca, Castilla Y LEÓN, Spain, 37006
Contact: Manuel José Vicente, MD    +34923 20 51 00      
Principal Investigator: Manuel José Vicente, MD         
Hospital Universitario de Salamanca Recruiting
Salamanca, Castilla Y LEÓN, Spain, 37007
Contact: Fernanda Lorenzo, MD    +34923 294 400      
Principal Investigator: Fernanda Lorenzo, MD         
CENTRO DE SALUD de PEÑARANDA Recruiting
Peñaranda de Bracamonte, Salamanca, Castilla Y LEÓN, Spain, 37300
Contact: Alfonso Sánchez, MD    +34923 54 16 00      
Principal Investigator: Alfonso Sánchez, MD         
United Kingdom
Royal Berkshire Hospital Nhs Foundation Trust Recruiting
Reading, London, United Kingdom, RG1 5AN
Contact: Stephen Foley, MBBS, FRCS    +441183228692      
Principal Investigator: Stephen Foley, MBBS, FRCS         
Sponsors and Collaborators
Inmunotek S.L.
Investigators
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Study Director: Fernanda Lorenzo, PhD; MD-prof
Principal Investigator: Isidoro Martín, PhD; MD
Principal Investigator: Alfonso Sánchez, PhD; MD
Principal Investigator: Manuel José Vicente, PhD; MD
Principal Investigator: Stephen Foley, FRCS (Urol)

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Responsible Party: Inmunotek S.L.
ClinicalTrials.gov Identifier: NCT02543827     History of Changes
Other Study ID Numbers: MV140-SLG-003
2013-001838-17 ( EudraCT Number )
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Inmunotek S.L.:
Vaccine
Recurrent Urinary Tract Infections (RUTI)

Additional relevant MeSH terms:
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Urinary Tract Infections
Bacterial Infections
Infection
Urologic Diseases