Recurrent Urinary Tract Infections MedDRA version: 17.1 Level: LLT Classification code 10038140 Term: Recurrent urinary tract infection System Organ Class: 100000004862
Conditions
Interventions
Product Code: MV140
Pharmaceutical Form: Sublingual spray, suspension
INN or Proposed INN: MV140
CAS Number: 8000045-24-1
Current Sponsor code: MV140
Other descriptive name: ALLERGENS, BACTERIA
Concen
Sponsors
Inmunotek, S.L.
INMUNOTEK, S.L.
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain the prevention of recurrent urinary tract infections in women immunized with the bacterial vaccine after a treatment of three or six months, compared with the placebo group.;Secondary Objective: -To compare the rate of episodes in the study time among groups of treatment compared with placebo. -Compare by a reason cost-benefit the three treatment groups. -Time elapsed from the beginning of treatment until the appearance of the first ITU. -Use of antibiotics as a prophylaxis and treatment of infections.;Primary end point(s): Average of diagnosed or symptomatic episodes of UTIs in study time.;Timepoint(s) of evaluation of this end point: At the beginning and after the treatment of 3 or 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -The proportion of immunized subjects resulting in a decrease in episodes of infections at 12 months. The overall rate of infections will be valued for this. -Consumption of healthcare resources: unscheduled visits to health center, visits to emergency admissions, days of hospital admission and cost the same, complementary tests carried out, phone calls to the doctor. -Immunological parameters. -Quality of life. -Visual scales of the investigator and patient. -Satisfaction questionnaire with the investigational medicinal product. -Use of antibiotics as a prophylaxis and treatment of infections. -Percentage of days without symptoms (scores equal to zero in the symptom score) throughout the trial. -Percentage of days without medication (score zero on the score of medication) throughout the trial.;Timepoint(s) of evaluation of this end point: - Baseline - Visit 1 (first IMP intake) - Visit 2 (3 months after visit 1) - Visit 3 (6 months after visit 2) - Visit 4 (9 months after visit 3) - Visit 5 (12 months after visit 1). | — |
Countries
Spain
Contacts
Public ContactMiguel Casanovas; Medical Director
Inmunotek, S.L.
Outcome results
None listed