Expanded Access Program Using Uromune for Patients With NCT04173013

Clinical Trial Details — Status: No longer available

Administrative data
NCT number	NCT04173013
Other study ID #	2019-UROMUNEINM-EU
Secondary ID
Status	No longer available
Phase
First received
Last updated

Study information
Verified date	September 2023
Source	Impatients N.V. trading as myTomorrows
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Expanded Access

Clinical Trial 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.

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%

Recruitment information / eligibility
Status	No longer available
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender	All
Age group	N/A and older
Eligibility	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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Uromune
2 sprays of solution once daily for a total of 3 months.

Locations
Country	Name	City
Belgium	Belgium	Brussels
Czechia	Czech Republic	Praha
Denmark	Denmark	Copenhagen
Finland	Finland	Helsinki
France	France	Paris
Germany	Germany	Berlin
Luxembourg	Luxembourg	Luxembourg
Netherlands	The Netherlands	Amsterdam
Norway	Norway	Oslo
Romania	Romania	Bukarest
Serbia	Serbia	Belgrade
Slovakia	Slovakia	Bratislava
Slovenia	Slovenia	Ljubljana
Sweden	Sweden	Stockholm
Turkey	Turkey	Istanbul

Sponsors *(2)*
Lead Sponsor	Collaborator
Impatients N.V. trading as myTomorrows	Inmunotek S.L.

Countries where clinical trial is conducted

Belgium, Czechia, Denmark, Finland, France, Germany, Luxembourg, Netherlands, Norway, Romania, Serbia, Slovakia, Slovenia, Sweden, Turkey,

References & 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. — View 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 — View 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 — View 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. — View Citation

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

Clinical Trial Details — Status: No longer available

Administrative data

Study information