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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04173013
Enrollment
Unknown
Registered
2019-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Infection, Chronic Urinary Tract Infection, Recurrent Urinary Tract Infection, Urinary Tract Infection Bacterial, Urinary Tract Infections

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%

Interventions

BIOLOGICALUromune

2 sprays of solution once daily for a total of 3 months.

Sponsors

Inmunotek S.L.
CollaboratorINDUSTRY
Impatients N.V. trading as myTomorrows
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

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.

Countries

Belgium, Czechia, Denmark, Finland, France, Germany, Luxembourg, Netherlands, Norway, Romania, Serbia, Slovakia, Slovenia, Sweden, Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026