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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173013
Expanded Access Status : Available
First Posted : November 21, 2019
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Inmunotek S.L.
Information provided by (Responsible Party):
Impatients N.V. trading as myTomorrows

Study Description
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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.

Condition or disease Intervention/treatment
Urinary Tract Infections Chronic Urinary Tract Infection Recurrent Urinary Tract Infection Urinary Tract Infection Bacterial Bladder Infection Biological: Uromune

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%
Study Design
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Study Type : Expanded Access
Official Title: Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Biological: Uromune
    2 sprays of solution once daily for a total of 3 months.
    Other Name: MV140
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173013


Contacts
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Contact: Michel van Harten, MD +31 885253888 inmunotek.medical@mytomorrows.com

Locations
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Belgium
Belgium Available
Brussels, Belgium
Czechia
Czech Republic Available
Praha, Czechia
Denmark
Denmark Available
Copenhagen, Denmark
Finland
Finland Available
Helsinki, Finland
France
France Available
Paris, France
Germany
Germany Available
Berlin, Germany
Luxembourg
Luxembourg Available
Luxembourg, Luxembourg
Netherlands
The Netherlands Available
Amsterdam, Netherlands
Norway
Norway Available
Oslo, Norway
Romania
Romania Available
Bukarest, Romania
Serbia
Serbia Available
Belgrade, Serbia
Slovakia
Slovakia Available
Bratislava, Slovakia
Slovenia
Slovenia Available
Ljubljana, Slovenia
Sweden
Sweden Available
Stockholm, Sweden
Turkey
Turkey Available
Istanbul, Turkey
Sponsors and Collaborators
Impatients N.V. trading as myTomorrows
Inmunotek S.L.
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Impatients N.V. trading as myTomorrows
ClinicalTrials.gov Identifier: NCT04173013    
Other Study ID Numbers: 2019-UROMUNEINM-EU
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Bacterial Infections
Cystitis
Recurrence
Disease Attributes
Pathologic Processes
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Bacterial Infections and Mycoses
Urinary Bladder Diseases