Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)
NCT ID: NCT04173013
Last Updated: 2023-09-29
Study Results
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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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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* Klebsiella pneumoniae 25%
* Escherichia coli 25%
* Enterococcus faecalis 25%
* Proteus vulgaris 25%
Conditions
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Interventions
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Uromune
2 sprays of solution once daily for a total of 3 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy and breast feeding. There are neither specific studies nor a formal contraindication, the physician should value benefits/risk.
ALL
No
Sponsors
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Inmunotek S.L.
INDUSTRY
Impatients N.V. trading as myTomorrows
INDUSTRY
Responsible Party
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Locations
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Belgium
Brussels, , Belgium
Czech Republic
Prague, , Czechia
Denmark
Copenhagen, , Denmark
Finland
Helsinki, , Finland
France
Paris, , France
Germany
Berlin, , Germany
Luxembourg
Luxembourg, , Luxembourg
The Netherlands
Amsterdam, , Netherlands
Norway
Oslo, , Norway
Romania
Bucharest, , Romania
Serbia
Belgrade, , Serbia
Slovakia
Bratislava, , Slovakia
Slovenia
Ljubljana, , Slovenia
Sweden
Stockholm, , Sweden
Turkey
Istanbul, , Turkey (Türkiye)
Countries
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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.
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.
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.
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.
Other Identifiers
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2019-UROMUNEINM-EU
Identifier Type: -
Identifier Source: org_study_id
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