Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)
1 other identifier
expanded_access
N/A
13 countries
13
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.
Trial Health
Trial Health Score
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13 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 21, 2019
CompletedSeptember 29, 2023
September 1, 2023
November 20, 2019
September 27, 2023
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Patients suffering recurrent urinary tract infections of diverse etiology.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Impatients N.V. trading as myTomorrowslead
- Inmunotek S.L.collaborator
Study Sites (15)
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)
Related Publications (4)
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.
PMID: 27966556BACKGROUNDYang 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.
PMID: 29171130RESULTLorenzo-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.
PMID: 26090341RESULTRamirez 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.
PMID: 31660885RESULT