Clinical trial NCT04049994: Immunomodulation Therapy for Urinary Tract Infections
Official title: Immunomodulation Therapy for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury During First Rehabilitation: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Cord Injuries
Urinary Tract Infections
Keywords: spinal cord injury
neurogenic lower urinary tract dysfunction
urinary tract infection
immunotherapy
immunomodulation
immunostimulation
E. coli
Uro-Vaxom
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
Collaborators: name: Swiss Spinal Cord Injury Cohort Study (SwiSCI)
First posted: 2019-08-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: randomization rate
timeFrame: at study completion, an average of 2 years
Secondary outcomes:
measure: positive screening rate
timeFrame: at study completion, an average of 2 years
measure: retention rate
timeFrame: at study completion, an average of 2 years
measure: drop-out rate
timeFrame: at study completion, an average of 2 years
measure: urine culture result
timeFrame: during follow-up of 12 months
measure: change in urinary immunoglobulin A levels
timeFrame: time 0 and 12 months
measure: count of urinary tract infection
timeFrame: during follow-up of 12 months
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
affiliation: Swiss Paraplegic Centre
name: Jürgen Pannek, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krebs J, Stoyanov J, Wollner J, Valido E, Pannek J. Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot). Trials. 2021 Oct 4;22(1):677. doi: 10.1186/s13063-021-05630-w.