Spinal Cord Injuries, Urinary Tract Infections
Conditions
Keywords
spinal cord injury, neurogenic lower urinary tract dysfunction, urinary tract infection, immunotherapy, immunomodulation, immunostimulation, E. coli, Uro-Vaxom
Brief summary
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.
Interventions
DRUGUro-Vaxom
Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains.
DRUGPlacebo oral tablet
Placebo oral tablet
Sponsors
Swiss Spinal Cord Injury Cohort Study (SwiSCI)
Swiss Paraplegic Research, Nottwil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| randomization rate | at study completion, an average of 2 years | proportion of eligible patients who were enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| retention rate | at study completion, an average of 2 years | treatment-specific retention rate |
| drop-out rate | at study completion, an average of 2 years | rate of enrolled study participants who do not complete the study protocol |
| positive screening rate | at study completion, an average of 2 years | proportion of eligible patients who were screened |
| change in urinary immunoglobulin A levels | time 0 and 12 months | concentration (mg/dl) of immunoglobulin A in the urine |
| count of urinary tract infection | during follow-up of 12 months | occurrence of a symptomatic urinary tract infection |
| urine culture result | during follow-up of 12 months | bacteria species isolated from urine of study participants |
Countries
Switzerland
Outcome results
None listed