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    The EU Clinical Trials Register currently displays   42758   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2010-020882-25
    Sponsor's Protocol Code Number:SU5.6
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2010-020882-25
    A.3Full title of the trial
    Prospective Multicentre Randomized Double-Blind Placebo-Controlled Parallel Group Study on the Efficacy and Tolerability of StroVac® in Patients With Recurrent Symptomatic Bacterial Urinary Tract Infections
    Prospektive, multizentrische, randomisierte, doppelblinde, placebokontrollierte Parallelgruppenstudie zur Wirksamkeit und Verträglichkeit von StroVac® bei Patienten mit rezidivierenden, symptomatischen, bakteriellen Harnwegsinfektionen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the Efficacy and Tolerability of StroVac® in Patients With Recurrent Urinary Tract Infections
    Studie zur Untersuchung der Wirksamkeit und Verträglichkeit von StroVac® bei Patienten mit wiederkehrenden Harnwegsinfektionen
    A.3.2Name or abbreviated title of the trial where available
    RUDIS -Study
    A.4.1Sponsor's protocol code numberSU5.6
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorStrathmann GmbH & Co. KG
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportStrathmann GmbH & Co. KG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStrathmann GmbH & Co. KG
    B.5.2Functional name of contact point Medizinisch-Wissenschaftliche Abte
    B.5.3 Address:
    B.5.3.1Street AddressSellhopsweg 1
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code22459
    B.5.4Telephone number+49(0)40559050
    B.5.5Fax number+49(0)4055905100
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name StroVac
    D. of the Marketing Authorisation holderStrathmann GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Lyophilisate and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate and solvent for suspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent Symptomatic Bacterial Urinary Tract Infections
    E.1.1.1Medical condition in easily understood language
    One or more parts of the urinary system become infected caused by bacteria (e.g. bladder infection). Recurrent is defined as having at least 2 infections in 6 months, or 3 infections in 1 year.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10038140
    E.1.2Term Recurrent urinary tract infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    The study results will be used to maintain the approval of StroVac®
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    1. Männer und Frauen im Alter von 18 bis 80 Jahren
    2. Patienten mit einer mindestens einjährigen Vorgeschichte rezidivierender unkomplizierter symptomatischer bakterieller Harnwegsinfektionen
    3. Patienten mit mindestens fünf dokumentierten Episoden von unkomplizierten symptomatischen bakteriellen Harnwegsinfektionen während eines Zeitraumes von zwölf Monaten vor Studieneinschluss
    4. Patienten, die ihre unterschriebene Einwilligungs- und Datenschutzerklärung gegeben haben, nachdem sie über Wesen, Bedeutung und Tragweite der Studie und über die erwarteten erwünschten und unerwünschten Wirkungen des Prüfpräparates aufgeklärt wurden
    E.4Principal 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
    1. Komplizierte Harnwegsinfektionen oder andere Erkrankungen der Harnwege wie nicht-bakterielle Zystitis oder mit Obstruktion einhergehende Erkrankungen/Anomalien wie Blasen- oder Nierensteine, Ureterstrikturen oder gutartige Prostatahyperplasie mit Harnverhalt (Bestätigung durch Ultraschall von Nieren und Blase und Bestimmung einer Restharnmenge von mehr als 50 ml).

    2. Patienten mit überaktiver Blase (> 8 Miktionen pro Tag bei unauffälligem Urinbe-fund)
    3. Kontraindikationen für die Anwendung des Prüfpräparates:
    - Akute Infektionen, mit Ausnahme von urogenitalen Infektionen
    - Aktive Tuberkulose
    - Schwerwiegende hämatopoetische Erkrankungen
    - Schwerwiegende kardiovaskuläre und renale Erkrankungen
    - Erkrankungen des Immunsystems
    - Überempfindlichkeit auf StroVac®
    4. Störung der Immunität in Folge von Erkrankungen wir Diabetes mellitus mit in-stabilem Stoffwechselstatus oder Vorliegen manifester diabetischer Spätkomplikationen oder Leberinsuffizienz
    5. Bösartige Erkrankungen, die weniger als 5 Jahre zurück liegen (ausgenommen Basaliome)
    6. Strahlentherapie im Unterbauch (ohne zeitliche Begrenzung) oder Strahlenthera-pie eines anderen Körperbereichs innerhalb der letzten 5 Jahre vor Start der Studie oder geplant während der Studie
    7. Einnahme von nicht-erlaubter Vorbehandlung
    8. Geplante Einnahme oder Applikation von Begleitbehandlung, die während der Studie nicht erlaubt ist
    9. Stationärer Krankenhausaufenthalt innerhalb der letzten 12 Monate vor Studienbeginn bzw. geplanter Krankenhausaufenthalt während der Studie
    10. Bewohner von Altenheimen oder vergleichbaren Einrichtungen (12 Monate vor und während der Studie)
    11. Schwangerschaft und Stillzeit
    12. Frauen im gebärfähigen Alter, die keine medizinisch anerkannte Kontrazeptionsmethode praktizieren (Ausnahme: Zustand nach Hysterektomie oder sterilisierter Partner oder Menopause mit der letzten Regelblutung mindestens sechs Monate vor Studienstart)
    13. Anamnestischer oder aktueller Alkohol- oder Drogenmissbrauch
    14. Patienten, die aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt untergebracht wurden.
    15. Andere schwerwiegende körperliche oder geistige Erkrankungen, die die prüfplankonforme Studiendurchführung in Frage stellen oder die Beurteilung der Sicherheit bzw. die Bewertung des Prüfpräparates beeinträchtigen können
    16. Geschäftsunfähigkeit und/oder sonstige Umstände, die es dem Patienten nicht erlauben, Wesen, Bedeutung und Tragweite der klinischen Prüfung zu verstehen
    17. Unzuverlässigkeit oder mangelnde Kooperation des Patienten
    18. Sonstige Gründe, die nach Einschätzung des Prüfarztes gegen die Aufnahme des Patienten in die Studie sprechen (z.B. die körperliche oder geistige Unfähigkeit, einen qualitativ geeigneten Mittelstrahlurin zu gewinnen oder das Patienten-tagebuch ordnungsgemäß zu führen)
    19. Teilnahme an einer anderen klinischen Studie in den letzten zwölf Wochen vor und während der Studie
    20. Patienten, die Mitarbeiter des Studienzentrums, der Prüfer selbst oder Angehörige
    E.5 End points
    E.5.1Primary 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.
    Primärer Endpunkt ist die Anzahl der bakteriellen Harnwegsinfektionen bestätigten bakteriellen Ursprungs während eines Zeitraumes von 13.5 Monaten beginnend nach Randomisierung und adjustiert nach dem entsprechenden Ausgangswert (ITT- Population). Der Ausgangswert ist definiert als Anzahl von dokumentierten HWI-Rezidiven während eines Zeitraumes von 12 Monaten vor Studieneinschluss.
    E.5.1.1Timepoint(s) of evaluation of this end point
    see E 5.1 description of endpoint
    E.5.2Secondary 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 number of patients per centre is low, centre effects were only considered for sensitivity analysis . For this sensitivity analysis no subgroup calculations will be done and all centres with less than 5 patients will be pooled.

    Secondary endpoints 3,4 and 5 will be additionally analyzed for either patient reported or confirmed UTIs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E 5.2 described for each endpoint
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned40
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months39
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months39
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state370
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    normal treatment
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-19
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