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

NCT ID: NCT04173013

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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%

Conditions

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

Interventions

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Uromune

2 sprays of solution once daily for a total of 3 months.

Intervention Type BIOLOGICAL

Other Intervention Names

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MV140

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inmunotek S.L.

INDUSTRY

Sponsor Role collaborator

Impatients N.V. trading as myTomorrows

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Belgium

Brussels, , Belgium

Site Status

Czech Republic

Prague, , Czechia

Site Status

Denmark

Copenhagen, , Denmark

Site Status

Finland

Helsinki, , Finland

Site Status

France

Paris, , France

Site Status

Germany

Berlin, , Germany

Site Status

Luxembourg

Luxembourg, , Luxembourg

Site Status

The Netherlands

Amsterdam, , Netherlands

Site Status

Norway

Oslo, , Norway

Site Status

Romania

Bucharest, , Romania

Site Status

Serbia

Belgrade, , Serbia

Site Status

Slovakia

Bratislava, , Slovakia

Site Status

Slovenia

Ljubljana, , Slovenia

Site Status

Sweden

Stockholm, , Sweden

Site Status

Turkey

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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

References

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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.

Reference Type BACKGROUND
PMID: 27966556 (View on PubMed)

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.

Reference Type RESULT
PMID: 29171130 (View on PubMed)

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.

Reference Type RESULT
PMID: 26090341 (View on PubMed)

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.

Reference Type RESULT
PMID: 31660885 (View on PubMed)

Other Identifiers

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2019-UROMUNEINM-EU

Identifier Type: -

Identifier Source: org_study_id

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