Immunomodulation Therapy for Urinary Tract Infections

Study Overview
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Brief Summary
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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.

Official Title
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Immunomodulation Therapy for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury During First Rehabilitation: a Randomized Controlled Pilot Study

Conditions
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Spinal Cord Injuries, Urinary Tract Infections

Intervention / Treatment
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* Drug: Uro-Vaxom
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunomodulation<br>Lyophilized lysate of 18 E. coli strains (6 mg) for oral application. A treatment lasts 90 days (one capsule daily). | Drug: Uro-Vaxom<br>* Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains.<br>|
| Placebo Comparator: Placebo<br>Oral placebo tablet once daily for 90 days. | Drug: Placebo oral tablet<br>* Placebo oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| randomization rate | proportion of eligible patients who were enrolled | at study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive screening rate | proportion of eligible patients who were screened | at study completion, an average of 2 years | 
| retention rate | treatment-specific retention rate | at study completion, an average of 2 years | 
| drop-out rate | rate of enrolled study participants who do not complete the study protocol | at study completion, an average of 2 years | 
| urine culture result | bacteria species isolated from urine of study participants | during follow-up of 12 months | 
| change in urinary immunoglobulin A levels | concentration (mg/dl) of immunoglobulin A in the urine | time 0 and 12 months | 
| count of urinary tract infection | occurrence of a symptomatic urinary tract infection | during follow-up of 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, neurogenic lower urinary tract dysfunction, urinary tract infection, immunotherapy, immunomodulation, immunostimulation, E. coli, Uro-Vaxom