Expanded Access Program Using Uromune for Patients With R... | NCT04173013

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

NCT04173013

Sponsor

Impatients N.V. trading as myTomorrows

Status

No longer available

Last Update Posted

Sep 29, 2023Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Urinary Tract Infections
Chronic Urinary Tract Infection
Recurrent Urinary Tract Infection
Urinary Tract Infection Bacterial
Bladder Infection

Interventions

Uromune

Countries

Belgium
Czechia
Denmark
Finland
France
Germany
Luxembourg
Netherlands
Norway
Romania
Serbia
Slovakia
Slovenia
Sweden
Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 20, 2019

First Submission Date that Met QC Criteria

Nov 20, 2019

First Posted Date

Nov 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2023

Last Update Posted Date

Sep 29, 2023Actual

Name	Class
Inmunotek S.L.	INDUSTRY

Description Module

Brief Summary

An Expanded Access Program for UROMUNE® for patients suffering from recurrent/chronic urinary tract infections of diverse etiology. This is for individuals for whom antibiotic therapy has failed, but of consideration in all cases, taking into account antibiotic-induced adverse reactions and increasing antibiotic resistance.

Detailed 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%

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Uromune	Biological	2 sprays of solution once daily for a total of 3 months.		MV140

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Belgium		Brussels			Belgium
Czech Republic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27966556	Background	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.
29171130

ID	Term
D014552	Urinary Tract Infections
D003556	Cystitis

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D001745	Urinary Bladder Diseases