E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent Urinary Tract Infections |
Infecciones de repetición del tracto urinario |
|
E.1.1.1 | Medical condition in easily understood language |
Recurrent Urinary Tract Infections |
Infecciones urinarias de repetición |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038140 |
E.1.2 | Term | Recurrent urinary tract infection |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Obtener la prevención de las Infecciones Urinarias Recurrentes en las mujeres inmunizadas con la vacuna bacteriana tras un tratamiento de tres o seis meses, en comparación con el grupo placebo. |
|
E.2.2 | Secondary objectives of the trial |
-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. |
- Comparar la tasa de episodios en el tiempo del estudio entre los grupos de tratamiento frente al placebo. - Comparar mediante una razón coste-beneficio los tres grupos de tratamiento. - Tiempo transcurrido desde el inicio del tratamiento hasta la aparición de la primera ITU. - Uso de antibióticos como profilaxis y tratamiento de infecciones. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
- Haber otorgado el consentimiento informado por escrito. - Mujeres - Edad comprendida entre 18 y 75 años. - Deben ser capaces de cumplir el régimen de dosificación. - Sujetos que hayan tenido, como mínimo, 3 episodios de cistitis en los últimos 12 meses. - Sujetos que no hayan respondido a medidas higiénico-sanitarias y/o tratamientos supresivos y/o profilaxis postcoital. |
|
E.4 | Principal 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. |
- No hayan otorgado el consentimiento informado por escrito. - Edad no comprendida en el rango de edad establecido. - No puedan ofrecer cooperación y/o tengan trastornos psiquiátricos graves. - Presenten residuo postmiccional patológico. - Presenten incontinencia moderada-grave. - Presenten tumores genitales. - Padezcan tumores en vías urinarias. - Presenten litiasis. - Presenten alteraciones en el sistema inmunológico. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Average of diagnosed or symptomatic episodes of UTIs in study time. |
Media de episodios diagnosticados o sintomáticos de ITUs en el tiempo de estudio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the beginning and after the treatment of 3 or 6 months. |
Al inicio y después del tratamiento a 3 o 6 meses. |
|
E.5.2 | 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. |
- La proporción de sujetos inmunizados que alcance una disminución de episodios de infecciones a los 12 meses. Para ello se valorará la tasa global de infecciones. - Consumo de recursos sanitarios: visitas a centro de salud no programadas, visitas a urgencias hospitalarias, días de ingreso hospitalario y coste del mismo, pruebas complementarias realizadas, llamadas telefónicas al médico especialista. - Parámetros inmunológicos. - Calidad de Vida. - Escalas visuales del investigador y paciente. - Cuestionario de satisfacción con el medicamento en investigación. - Uso de antibióticos como profilaxis y tratamiento de infecciones. - Porcentaje de días sin síntomas (puntuación igual a cero en la puntuación de síntomas) a lo largo del ensayo. - Porcentaje de días sin medicación (puntuación igual a cero en la puntuación de medicación) a lo largo del ensayo. |
|
E.5.2.1 | 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). |
- Visita basal - Visita 1 (primera toma del medicamento en investigación) - Visita 2 (3 meses después de visita 1) - Visita 3 (6 meses después de visita 2) - Visita 4 (9 meses después de visita 3) - Visita 5 (12 meses después de visita 1) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial will be finished when the data base will be closed out. |
El ensayo finalizará cuando se realice el cierre de la base de datos |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |