Urinary Tract InfectionsNCT04173013
Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)
A study testing Uromune in people with Urinary Tract Infections and Chronic Urinary Tract Infection, run by Impatients N.V. trading as myTomorrows at 15 sites in 15 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infections, Chronic Urinary Tract Infection, Recurrent Urinary Tract Infection
- What is being tested?
- Uromune
- How many people
- Not given
- Where
- 15 sitesin 15 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients suffering recurrent urinary tract infections of diverse etiology.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 15 countries.
15 sites in 15 countries
About this study
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.
Read the 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%
- Conditions
- Urinary Tract Infections, Chronic Urinary Tract Infection, Recurrent Urinary Tract Infection, Urinary Tract Infection Bacterial, Bladder Infection
- Being tested
- Uromune
- Medical subject headings
- Urinary Tract Infections, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UromuneBiological
Also called MV140
2 sprays of solution once daily for a total of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Impatients N.V. trading as myTomorrows
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inmunotek S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173013
- Sponsor's protocol ID
- 2019-UROMUNEINM-EU
- Status last verified
- Sep 2023
- First submitted
- 20 Nov 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
Publications
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.
PubMed 27966556Yang 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.
PubMed 29171130Lorenzo-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.
PubMed 26090341Ramirez 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.
PubMed 31660885Doiron RC, Cotechini T, Nickel JC. It's Time to Embrace Vaccination as We Enter the Postantibiotic Era of Recurrent Urinary Tract Infection Management. J Urol. 2024 Jun;211(6):797-799. doi: 10.1097/JU.0000000000003969. Epub 2024 May 5. No abstract available.
PubMed 38704743
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)
- ClinicalTrials.gov ID
- NCT04173013
- Acronym / sponsor ID
- 2019-UROMUNEINM-EU
- Conditions
- Urinary Tract Infections, Chronic Urinary Tract Infection, Recurrent Urinary Tract Infection, Urinary Tract Infection Bacterial, Bladder Infection
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Impatients N.V. trading as myTomorrowsIndustry (pharma, biotech, devices)
- Collaborators
- Inmunotek S.L.
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering recurrent urinary tract infections of diverse etiology.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UromuneAlso: MV1402 sprays of solution once daily for a total of 3 months. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 27966556Benito-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 publication: PubMed 29171130Yang 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 publication: PubMed 26090341Lorenzo-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 publication: PubMed 31660885Ramirez 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.
- Derived from this study: PubMed 38704743Doiron RC, Cotechini T, Nickel JC. It's Time to Embrace Vaccination as We Enter the Postantibiotic Era of Recurrent Urinary Tract Infection Management. J Urol. 2024 Jun;211(6):797-799. doi: 10.1097/JU.0000000000003969. Epub 2024 May 5. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uromune in people with Urinary Tract Infections and Chronic Urinary Tract Infection, run by Impatients N.V. trading as myTomorrows at 15 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium, Czechia, Denmark, Finland, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04173013, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.