Clinical Trials Register

Summary
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

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - PEI

A.2

EudraCT number

2010-020882-25

A.3

Full 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.3.1

Title 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.3.2

Name or abbreviated title of the trial where available

RUDIS -Study

RUDIS-Studie

A.4.1

Sponsor's protocol code number

SU5.6

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Strathmann GmbH & Co. KG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Strathmann GmbH & Co. KG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Strathmann GmbH & Co. KG
B.5.2	Functional name of contact point	Medizinisch-Wissenschaftliche Abte
B.5.3	Address:
B.5.3.1	Street Address	Sellhopsweg 1
B.5.3.2	Town/ city	Hamburg
B.5.3.3	Post code	22459
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49(0)40559050
B.5.5	Fax number	+49(0)4055905100
B.5.6	E-mail	Verteiler_MW@strathmann.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	StroVac
D.2.1.1.2	Name of the Marketing Authorisation holder	Strathmann GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Lyophilisate and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Lyophilisate and solvent for suspension for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Recurrent Symptomatic Bacterial Urinary Tract Infections

E.1.1.1

Medical 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.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
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

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary objectives of the trial

The study results will be used to maintain the approval of StroVac®

E.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

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.

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.5.1.1

Timepoint(s) of evaluation of this end point

see E 5.1 description of endpoint

E.5.2

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 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

370

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-11-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-11-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-03-19

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