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

Impatients

Status

Conditions: Urinary Tract Infections; Recurrent Urinary Tract Infection; Urinary Tract Infection Bacterial; Chronic Urinary Tract Infection; Bladder Infection

Treatments: Biological: Uromune

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04173013

2019-UROMUNEINM-EU

Details and patient eligibility

About

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.

Full 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%

Sex: All

Volunteers: No Healthy Volunteers

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.