Clinical trial NCT04173013: Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)
Official title: Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Urinary Tract Infections
Chronic Urinary Tract Infection
Recurrent Urinary Tract Infection
Urinary Tract Infection Bacterial
Bladder Infection
Lead sponsor: Impatients N.V. trading as myTomorrows
Sponsor class: INDUSTRY
Collaborators: name: Inmunotek S.L.
First posted: 2019-11-21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

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%

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Belgium
city: Praha
country: Czechia
facility: Czech Republic
city: Copenhagen
country: Denmark
facility: Denmark
city: Helsinki
country: Finland
facility: Finland
city: Paris
country: France
facility: France
city: Berlin
country: Germany
facility: Germany
city: Luxembourg
country: Luxembourg
facility: Luxembourg
city: Amsterdam
country: Netherlands
facility: The Netherlands
city: Oslo
country: Norway
facility: Norway
city: Bukarest
country: Romania
facility: Romania
city: Belgrade
country: Serbia
facility: Serbia
city: Bratislava
country: Slovakia
facility: Slovakia
city: Ljubljana
country: Slovenia
facility: Slovenia
city: Stockholm
country: Sweden
facility: Sweden
city: Istanbul
country: Turkey
facility: Turkey
Study officials:
References:
citation: 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.
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.
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 tract infections. Front Cell Infect Microbiol. 2015 Jun 3;5:50. doi: 10.3389/fcimb.2015.00050. eCollection 2015.
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. 2019 Oct 28;19(1):901. doi: 10.1186/s12879-019-4541-y.