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
- Study Details
- Tabular View
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Urinary Tract Infections Chronic Urinary Tract Infection Recurrent Urinary Tract Infection Urinary Tract Infection Bacterial Bladder Infection||Biological: Uromune|
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 Type :||Expanded Access|
|Official Title:||Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)|
- Biological: Uromune
2 sprays of solution once daily for a total of 3 months.Other Name: MV140
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.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
- Patients suffering recurrent urinary tract infections of diverse etiology.
- 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.
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
|Contact: Michel van Harten, MD||+31 email@example.com|
|Responsible Party:||Impatients N.V. trading as myTomorrows|
|Other Study ID Numbers:||
|First Posted:||November 21, 2019 Key Record Dates|
|Last Update Posted:||March 31, 2022|
|Last Verified:||February 2022|
Urinary Tract Infections
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Bacterial Infections and Mycoses
Urinary Bladder Diseases