Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)
Primary Purpose
Urinary Tract Infections, Chronic Urinary Tract Infection, Recurrent Urinary Tract Infection
Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Uromune
Sponsored by
About this trial
This is an expanded access trial for Urinary Tract Infections
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.
Sites / Locations
- Belgium
- Czech Republic
- Denmark
- Finland
- France
- Germany
- Luxembourg
- The Netherlands
- Norway
- Romania
- Serbia
- Slovakia
- Slovenia
- Sweden
- Turkey
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04173013
First Posted
November 20, 2019
Last Updated
September 27, 2023
Sponsor
Impatients N.V. trading as myTomorrows
Collaborators
Inmunotek S.L.
1. Study Identification
Unique Protocol Identification Number
NCT04173013
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impatients N.V. trading as myTomorrows
Collaborators
Inmunotek S.L.
4. Oversight
5. Study Description
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%
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Chronic Urinary Tract Infection, Recurrent Urinary Tract Infection, Urinary Tract Infection Bacterial, Bladder Infection
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Uromune
Other Intervention Name(s)
MV140
Intervention Description
2 sprays of solution once daily for a total of 3 months.
10. Eligibility
Sex
All
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.
Facility Information:
Facility Name
Belgium
City
Brussels
Country
Belgium
Facility Name
Czech Republic
City
Praha
Country
Czechia
Facility Name
Denmark
City
Copenhagen
Country
Denmark
Facility Name
Finland
City
Helsinki
Country
Finland
Facility Name
France
City
Paris
Country
France
Facility Name
Germany
City
Berlin
Country
Germany
Facility Name
Luxembourg
City
Luxembourg
Country
Luxembourg
Facility Name
The Netherlands
City
Amsterdam
Country
Netherlands
Facility Name
Norway
City
Oslo
Country
Norway
Facility Name
Romania
City
Bukarest
Country
Romania
Facility Name
Serbia
City
Belgrade
Country
Serbia
Facility Name
Slovakia
City
Bratislava
Country
Slovakia
Facility Name
Slovenia
City
Ljubljana
Country
Slovenia
Facility Name
Sweden
City
Stockholm
Country
Sweden
Facility Name
Turkey
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
27966556
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.
Results Reference
background
PubMed Identifier
29171130
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.
Results Reference
result
PubMed Identifier
26090341
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.
Results Reference
result
PubMed Identifier
31660885
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.
Results Reference
result
Learn more about this trial
Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)
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