Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

Studies

Study First Submitted Date 2019-11-20
Study First Posted Date 2019-11-21
Last Update Posted Date 2022-03-31
Verification Month Year February 2022
Verification Date 2022-02-28
Last Update Posted Date 2022-03-31

Detailed Descriptions

Sequence: 20811050
Description UROMUNE® is a mucosal immunotherapy indicated for the prevention of urinary tract infections caused by different pathogens. It works by stimulating the immune system, thus increasing the resistance against recurrent infections. The active substances are 4 inactivated and selected bacterial strains:

Klebsiella pneumoniae 25%
Escherichia coli 25%
Enterococcus faecalis 25%
Proteus vulgaris 25%

Facilities

Sequence: 200862779 Sequence: 200862780 Sequence: 200862781 Sequence: 200862782 Sequence: 200862783 Sequence: 200862784 Sequence: 200862785 Sequence: 200862786 Sequence: 200862787 Sequence: 200862788 Sequence: 200862789 Sequence: 200862790 Sequence: 200862791 Sequence: 200862792 Sequence: 200862793
Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available
Name Belgium Name Czech Republic Name Denmark Name Finland Name France Name Germany Name Luxembourg Name The Netherlands Name Norway Name Romania Name Serbia Name Slovakia Name Slovenia Name Sweden Name Turkey
City Brussels City Praha City Copenhagen City Helsinki City Paris City Berlin City Luxembourg City Amsterdam City Oslo City Bukarest City Belgrade City Bratislava City Ljubljana City Stockholm City Istanbul
Country Belgium Country Czechia Country Denmark Country Finland Country France Country Germany Country Luxembourg Country Netherlands Country Norway Country Romania Country Serbia Country Slovakia Country Slovenia Country Sweden Country Turkey

Conditions

Sequence: 52399266 Sequence: 52399267 Sequence: 52399268 Sequence: 52399269 Sequence: 52399270
Name Urinary Tract Infections Name Chronic Urinary Tract Infection Name Recurrent Urinary Tract Infection Name Urinary Tract Infection Bacterial Name Bladder Infection
Downcase Name urinary tract infections Downcase Name chronic urinary tract infection Downcase Name recurrent urinary tract infection Downcase Name urinary tract infection bacterial Downcase Name bladder infection

Id Information

Sequence: 40320486
Id Source org_study_id
Id Value 2019-UROMUNEINM-EU

Countries

Sequence: 42743716 Sequence: 42743717 Sequence: 42743718 Sequence: 42743719 Sequence: 42743720 Sequence: 42743721 Sequence: 42743722 Sequence: 42743723 Sequence: 42743724 Sequence: 42743725 Sequence: 42743726 Sequence: 42743727 Sequence: 42743728 Sequence: 42743729 Sequence: 42743730
Name Belgium Name Czechia Name Denmark Name Finland Name France Name Germany Name Luxembourg Name Netherlands Name Norway Name Romania Name Serbia Name Slovakia Name Slovenia Name Sweden Name Turkey
Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False

Interventions

Sequence: 52708420
Intervention Type Biological
Name Uromune
Description 2 sprays of solution once daily for a total of 3 months.

Browse Conditions

Sequence: 194353556 Sequence: 194353557 Sequence: 194353558 Sequence: 194353559 Sequence: 194353560 Sequence: 194353561 Sequence: 194353562 Sequence: 194353563 Sequence: 194353564 Sequence: 194353565 Sequence: 194353566 Sequence: 194353567 Sequence: 194353568 Sequence: 194353569 Sequence: 194353570
Mesh Term Infections Mesh Term Communicable Diseases Mesh Term Urinary Tract Infections Mesh Term Bacterial Infections Mesh Term Cystitis Mesh Term Recurrence Mesh Term Disease Attributes Mesh Term Pathologic Processes Mesh Term Urologic Diseases Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Male Urogenital Diseases Mesh Term Bacterial Infections and Mycoses Mesh Term Urinary Bladder Diseases
Downcase Mesh Term infections Downcase Mesh Term communicable diseases Downcase Mesh Term urinary tract infections Downcase Mesh Term bacterial infections Downcase Mesh Term cystitis Downcase Mesh Term recurrence Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes Downcase Mesh Term urologic diseases Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term male urogenital diseases Downcase Mesh Term bacterial infections and mycoses Downcase Mesh Term urinary bladder diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48531724 Sequence: 48531725
Agency Class INDUSTRY Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Impatients N.V. trading as myTomorrows Name Inmunotek S.L.

Central Contacts

Sequence: 12068002
Contact Type primary
Name Michel van Harten, MD
Phone +31 885253888
Email inmunotek.medical@mytomorrows.com
Role Contact

Eligibilities

Sequence: 30896815
Gender All
Minimum Age N/A
Maximum Age N/A
Criteria Inclusion Criteria:

Patients suffering recurrent urinary tract infections of diverse etiology.

Exclusion Criteria:

Individuals being allergic to any of the ingredients of UROMUNE®.
Pregnancy and breast feeding. There are neither specific studies nor a formal contraindication, the physician should value benefits/risk.

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254144212
Number Of Facilities 15
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility False

Intervention Other Names

Sequence: 26784475
Intervention Id 52708420
Name MV140

Responsible Parties

Sequence: 29009164
Responsible Party Type Sponsor

Study References

Sequence: 52309366 Sequence: 52309367 Sequence: 52309368 Sequence: 52309369
Pmid 27966556 Pmid 29171130 Pmid 26090341 Pmid 31660885
Reference Type background Reference Type result Reference Type result Reference Type result
Citation Benito-Villalvilla C, Cirauqui C, Diez-Rivero CM, Casanovas M, Subiza JL, Palomares O. MV140, a sublingual polyvalent bacterial preparation to treat recurrent urinary tract infections, licenses human dendritic cells for generating Th1, Th17, and IL-10 responses via Syk and MyD88. Mucosal Immunol. 2017 Jul;10(4):924-935. doi: 10.1038/mi.2016.112. Epub 2016 Dec 14. Citation Yang B, Foley S. First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune(R). BJU Int. 2018 Feb;121(2):289-292. doi: 10.1111/bju.14067. Epub 2017 Nov 23. Citation Lorenzo-Gomez MF, Padilla-Fernandez B, Garcia-Cenador MB, Virseda-Rodriguez AJ, Martin-Garcia I, Sanchez-Escudero A, Vicente-Arroyo MJ, Miron-Canelo JA. Comparison of sublingual therapeutic vaccine with antibiotics for the prophylaxis of recurrent urinary tract infections. Front Cell Infect Microbiol. 2015 Jun 3;5:50. doi: 10.3389/fcimb.2015.00050. eCollection 2015. Citation Ramirez Sevilla C, Gomez Lanza E, Manzanera JL, Martin JAR, Sanz MAB. Active immunoprophyilaxis with uromune(R) decreases the recurrence of urinary tract infections at three and six months after treatment without relevant secondary effects. BMC Infect Dis. 2019 Oct 28;19(1):901. doi: 10.1186/s12879-019-4541-y.