Recurrent Symptomatic Bacterial Urinary Tract Infections MedDRA version: 17.0 Level: LLT Classification code 10038140 Term: Recurrent urinary tract infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: StroVac
Pharmaceutical Form: Lyophilisate and solvent for suspension for injection
Pharmaceutical form of the placebo: Lyophilisate and solvent for suspension for injection
Route of admini
Sponsors
Strathmann GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18 to 80 years 2. Patients with a history of at least one year of recurrent uncomplicated symptomatic bacterial urinary tract infections 3. Patients with at least five confirmed episodes of uncomplicated symp-tomatic bacterial urinary tract infections during a period of twelve months prior to study inclusion 4. Patients who have given their signed declaration of consent and data protection declaration after having been informed about the nature, relevance and the scope of the study and about the expected desired and undesired effects of the investigative medicinal product 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 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Complicated urinary tract infections or other diseases of the urinary tract such as non-bacterial cystitis or diseases/anomalies associated with an obstruction such as bladder or kidney stones, strictures of ureter or benign prostatic hyperplasia with urinary retention (Confirmation by ultrasound of kidney and bladder and determination of residual amount of > 50 ml urine). 2. Patients suffering from overactive bladder (> 8 micturitions per day and clinically not significant urinanalysis) 3. Contraindications for the application of the investigational medicinal product - Acute infectious diseases, excluding urogenital diseases - Active tuberculosis - Severe diseases of the hematopoietic system - Severe cardiac or renal disease - Diseases of the immune system - Hypersensitivity towards StroVac® 4. Malfunction of immunity as a result of diseases like diabetes mellitus with instable metabolic status or presence of manifest late diabetic complications or liver insufficiency 5. Any malignancy less than 5 years ago (except basal cell carcinoma) 6. Any radiation therapy of the abdomen (without time limitation) or radiation therapy of another body part within the last 5 years prior to start of study or planned during study 7. Intake of not permitted previous therapy 8. Planned intake or application of concomitant therapy which is not per-mitted during the study 9. Hospitalization within the last 12 months prior to study start or planned during the study 10. Inhabitants of nursing homes or comparable institutions (12 months be-fore study and during study) 11. Pregnancy and lactation 12. Women of childbearing age, who do not use a medically accepted method of contraceptional method unless in case of post-hysterecomy or sterilized partner or menopause with last period at least 6 months prior to study start 13. Current or previous abuse of alcohol or drugs 14. Patients in custody by juridical or official order. 15. Other severe physical or mental diseases which challenge the conduct of the study according to protocol or impact the evaluation of the efficacy or safety of the product or the safety of the patient 16. Patient is incapable of contracting or other circumstances which do not allow the patient to understand type, relevance and reach of the clinical trial 17. Unreliability or lack of cooperation by the patient 18. Other reasons against participation in the study in the opinion of the Investigator (e.g. patient’s physical or mental disability to collect a qualitative sample of midstream urine or to complete the diary) 19. Participation in another clinical study within 12 weeks prior to study start and during study 20. Patients who are part of the staff of the study centre, the Investigator him/herself or close relatives of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the clinical efficacy and tolerability of the inactivated germs of specified enterobacteria contained in StroVac® in recurrent acute uncomplicated symptomatic bacterial urinary tract infections as compared to placebo. ;Secondary Objective: The study results will be used to maintain the approval of StroVac® ;Timepoint(s) of evaluation of this end point: see E 5.1 description of endpoint;Primary end point(s): The primary endpoint is defined as the number of bacterial urinary tract recurrences with confirmed bacterial origin over a period of 13.5 months starting after randomization and adjusted by the respective “Baseline” value (ITT-population). The “Baseline” is defined as the number of confirmed UTI recurrences during the 12 months-period prior to study inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of bacterial UTI recurrences with confirmed bacterial origin within a period of 12 months starting after finalization of the immunization scheme 2. Number of recurring bacterial urinary tract infections either with confirmed bacterial origin or only patient reported over a period of - 13.5 starting after randomization - 12 months starting after finalisation of the immunization scheme. 3. Time interval until occurrence of the first confirmed recurrent UTI after finalisation of the randomization starting starting at - V2 (randomization) - V5 (after finalisation of the immunization scheme) 4. The area under the “number of confirmed recurrences versus time” curve from for the periods V2-V5, V2-V9, V5-V6 (6 weeks), V5-V7 (6 months), V5-V8 (9.5 months) and V5-V9 (12 months) separately for each period including “Baseline” and “Duration of period” as covariates and treatment and menopausal status (pre-/postmenopausal) as factors. 5. Frequency of confirmed UTI recurrences during the first six months after finalisation of the immunization scheme (V5-V7) as compared to months 7 to 12 (V7-V9) will be performed separately for each treatment 6. Difference in the percentage of patients with no recurrences in the period of - 13.5 starting after randomization - 12 months starting after finalisation of the immunization scheme between StroVac and placebo. 7. Quality of life 8. Investigator’s and patient’s global judgement on efficacy 9. Difference in the percentage of patients classified as responders (treatment responders) by the global investigator and patient’s assessment (very good or good) between StroVac and placebo. 10. The primary endpoint and the secondary endpoints 1.- 9. will be analyzed for the subgroup(s) of - patients with infection rates above average during the period of 12 months prior to study inclusion - pre- and postmenopausal women 11. Because it is expected that the n | — |
Countries
Germany
Contacts
Public ContactMedizinisch-Wissenschaftliche Abte
Strathmann GmbH & Co. KG
Outcome results
None listed