Immunomodulation Therapy for Urinary Tract Infections

Swiss Paraplegic Research, Nottwil24 enrolled

Overview

Urinary tract infections (UTI) represent one of the most common morbidities in individuals with spinal cord injury (SCI) and reason for re-hospitalization. The consequences of recurrent UTI are a decrease in quality of life and considerable health costs. Immunomodulation therapy with UroVaxom is a very promising method for the prevention of UTI, however data in individuals with SCI are very limited. The primary objective of this pilot study is to evaluate the feasibility (recruitment rate, patient attrition, compliance, assessment procedures etc.) of a main trial. A secondary objective is to collect data for an informed sample size calculation. Furthermore, the clinical and biological changes after immunomodulation therapy will be investigated. This is a randomized, placebo-controlled, mono-centric pilot study investigating the feasibility of a main trial regarding the effectiveness of immunomodulation with UroVaxom in the prevention of UTI and the effect on the immune system in individuals with acute SCI during primary rehabilitation. There will be two parallel groups of 12 participants each. Group allocation will be based on a block-randomization stratified according to sex. Study participants and outcome assessors will be blinded to the group allocation. The nursing staff will be unblinded and will administer the treatment and the placebo. Study participants will either receive Uro-Vaxom (one tablet / day) or an off-the-shelf placebo for 90 days. After termination of the treatment, the study participants will be followed for 12 months. Blood and urine samples will be taken before and 90 days, 6 months and 12 months after treatment start.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * acute SCI (within 8 weeks after SCI) * onset of SCI within 72h * age from 18 to 70 years * informed consent as documented by signature Exclusion Criteria: * known hypersensitivity to investigational product, * other immunomodulation therapy, * immunosuppressant therapy, * oncological condition or therapy, * autoimmune diseases, nephropathy, bladder stones, * women who are pregnant (pregnancy test) or breast feeding, * participation in another study with an investigational drug within the 30 days preceding and during the present study

Outcomes

Primary Outcomes

randomization rate

proportion of eligible patients who were enrolled

Time frame: at study completion, an average of 2 years

Secondary Outcomes

positive screening rate

proportion of eligible patients who were screened

Time frame: at study completion, an average of 2 years

retention rate

treatment-specific retention rate

Time frame: at study completion, an average of 2 years

drop-out rate

rate of enrolled study participants who do not complete the study protocol

Time frame: at study completion, an average of 2 years

urine culture result

bacteria species isolated from urine of study participants

Time frame: during follow-up of 12 months

change in urinary immunoglobulin A levels

concentration (mg/dl) of immunoglobulin A in the urine

Time frame: time 0 and 12 months

count of urinary tract infection

occurrence of a symptomatic urinary tract infection

Time frame: during follow-up of 12 months

Immunomodulation Therapy for Urinary Tract Infections

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes